{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 7 } }, "results": [ { "cfres_id": "217699", "product_res_number": "Z-1123-2026", "event_date_initiated": "2025-12-04", "event_date_posted": "2026-01-16", "recall_status": "Open, Classified", "res_event_number": "98139", "product_code": "PTM", "product_description": "Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL\n\nReference Numbers: ENDO-AN2030/B\tIN4130/CNK\tIN4130/H\tIN4130/JPH\tIN4130/K\tIN4130/KRK\tIN4130/L\tIN4130/T\tIN4230/JPH\tIN4230/K\tIN4330/CNK\tIN4330/K\tIN4352/K\tIN4430/K\tIN4530/CNK\tIN4530/K\tIN4530/T\tIN4802/K\tIN4802/T\tIN4852/K\tIN4901/A\tIN4902/A\tIN4903/A\tIN4904/A\tIN4905/A\tIN4906/A\tIN4907/A\tIN4908\tIN4909\tIN4910\tIN4911/A\tIN4912\tIN4913/A\tIN4914/A\tIN4915\tIN4916/A\tIN4917/A\tIN4918/A\tIN4919/A", 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Number(s)\nENDO-AN2030/B\t00884450645161\tI2559664\n\t00884450645161\tI2617758\n\t00884450645161\tI2622046\n\t00884450645161\tI2657805\n\t00884450645161\tI2937082\n\t00884450645161\tI3056430\n\t00884450645161\tI3085664\n\t00884450645161\tI3118225\n\t00884450645161\tI3251180\n\t00884450645161\tI3282751\nIN4130/CNK\t00884450636695\tI2559550\n\t00884450636695\tI2559551\n\t00884450636695\tI2563338\n\t00884450636695\tI2563339\n\t00884450636695\tI2563340\n\t00884450636695\tI2564655\n\t00884450636695\tI2564665\n\t00884450636695\tI2567481\n\t00884450636695\tI2567482\n\t00884450636695\tI2567483\n\t00884450636695\tI2578099\n\t00884450636695\tI2578100\n\t00884450636695\tI2584021\n\t00884450636695\tI2584024\n\t00884450636695\tI2584025\n\t00884450636695\tI2584026\n\t00884450636695\tI2607299\n\t00884450636695\tI2607301\n\t00884450636695\tI2607302\n\t00884450636695\tI2617759\n\t00884450636695\tI2617760\n\t00884450636695\tI2628998\n\t00884450636695\tI2629000\n\t00884450636695\tI2629001\n\t00884450636695\tI2629002\n\t00884450636695\tI2630702\n\t00884450636695\tI2648658\n\t00884450636695\tI2648659\n\t00884450636695\tI2648660\n\t00884450636695\tI2648661\n\t00884450636695\tI2657828\n\t00884450636695\tI2657833\n\t00884450636695\tI2657884\n\t00884450636695\tI2657889\n\t00884450636695\tI2663025\n\t00884450636695\tI2663026\n\t00884450636695\tI2663027\n\t00884450636695\tI2669899\n\t00884450636695\tI2669900\n\t00884450636695\tI2674531\n\t00884450636695\tI2674532\n\t00884450636695\tI2682701\n\t00884450636695\tI2682702\n\t00884450636695\tI2684463\n\t00884450636695\tI2684522\n\t00884450636695\tI2684523\n\t00884450636695\tI2699591\n\t00884450636695\tI2699592\n\t00884450636695\tI2703002\n\t00884450636695\tI2703003\n\t00884450636695\tI2703004\n\t00884450636695\tI2703006\n\t00884450636695\tI2703081\n\t00884450636695\tI2703082\n\t00884450636695\tI2703083\n\t00884450636695\tI2707735\n\t00884450636695\tI2707736\n\t00884450636695\tI2715012\n\t00884450636695\tI2715013\n\t00884450636695\tI2719928\n\t00884450636695\tI2719929\n\t00884450636695\tI2719930\n\t00884450636695\tI2719931\n\t00884450636695\tI2719933\n\t00884450636695\tI2752077\n\t00884450636695\tI2752078\n\t00884450636695\tI2755218\n\t00884450636695\tI2755219\n\t00884450636695\tI2755496\n\t00884450636695\tI2760565\n\t00884450636695\tI2773971\n\t00884450636695\tI2773972\n\t00884450636695\tI2784600\n\t00884450636695\tI2784603\n\t00884450636695\tI2844301\n\t00884450636695\tI2853612\n\t00884450636695\tI2853613\n\t00884450636695\tI2853615\n\t00884450636695\tI2858649\n\t00884450636695\tI2858650\n\t00884450636695\tI2858651\n\t00884450636695\tI2869290\n\t00884450636695\tI2886413\n\t00884450636695\tI2886423\n\t00884450636695\tI2886429\n\t00884450636695\tI2886432\n\t00884450636695\tI2887831\n\t00884450636695\tI2887832\n\t00884450636695\tI2887836\n\t00884450636695\tI2888430\n\t00884450636695\tI2892032\n\t00884450636695\tI2892033\n\t00884450636695\tI2894577\n\t00884450636695\tI2902444\n\t00884450636695\tI2902445\n\t00884450636695\tI2902446\n\t00884450636695\tI2902447\n\t00884450636695\tI2903533\n\t00884450636695\tI2903535\n\t00884450636695\tI2917165\n\t00884450636695\tI2917167\n\t00884450636695\tI2921904\n\t00884450636695\tI2921905\n\t00884450636695\tI2927911\n\t00884450636695\tI2933517\n\t00884450636695\tI2937693\n\t00884450636695\tI2937694\n\t00884450636695\tI2971987\n\t00884450636695\tI2973163\n\t00884450636695\tI2973184\n\t00884450636695\tI2976519\n\t00884450636695\tI2976520\n\t00884450636695\tI2976521\n\t00884450636695\tI2983704\n\t00884450636695\tI2986048\n\t00884450636695\tI2986049\n\t00884450636695\tI2989136\n\t00884450636695\tI2989137\n\t00884450636695\tI3001128\n\t00884450636695\tI3001129\n\t00884450636695\tI3001130\n\t00884450636695\tI3001131\n\t00884450636695\tI3013083\n\t00884450636695\tI3013085\n\t00884450636695\tI3014308\n\t00884450636695\tI3014309\n\t00884450636695\tI3014311\n\t00884450636695\tI3014312\n\t00884450636695\tI3044881\n\t00884450636695\tI3048387\n\t00884450636695\tI3056432\n\t00884450636695\tI3056433\n\t00884450636695\tI3067548\n\t00884450636695\tI3067549\n\t00884450636695\tI3072605\n\t00884450636695\tI3074753\n\t00884450636695\tI3074754\n\t00884450636695\tI3074755\n\t00884450636695\tI3074756\n\t00884450636695\tI3079091\n\t00884450636695\tI3079092\n\t00884450636695\tI3079093\n\t00884450636695\tI3079094\n\t00884450636695\tI3079095\n\t00884450636695\tI3079096\n\t00884450636695\tI3085666\n\t00884450636695\tI3085667\n\t00884450636695\tI3085668\n\t00884450636695\tI3097690\n\t00884450636695\tI3097691\n\t00884450636695\tI3098952\n\t00884450636695\tI3098953\n\t00884450636695\tI3098955\n\t00884450636695\tI3118226\n\t00884450636695\tI3118227\n\t00884450636695\tI3118228\n\t00884450636695\tI3118230\n\t00884450636695\tI3129660\n\t00884450636695\tI3129661\n\t00884450636695\tI3129662\n\t00884450636695\tI3129663\n\t00884450636695\tI3129664\n\t00884450636695\tI3146015\n\t00884450636695\tI3146016\n\t00884450636695\tI3150024\n\t00884450636695\tI3150025\n\t00884450636695\tI3150028\n\t00884450636695\tI3150029\n\t00884450636695\tI3161167\n\t00884450636695\tI3161168\n\t00884450636695\tI3161169\n\t00884450636695\tI3161170\n\t00884450636695\tI3186043\n\t00884450636695\tI3186044\n\t00884450636695\tI3186047\n\t00884450636695\tI3186048\n\t00884450636695\tI3186064\n\t00884450636695\tI3186065\n\t00884450636695\tI3204095\n\t00884450636695\tI3204096\n\t00884450636695\tI3204119\n\t00884450636695\tI3204120\n\t00884450636695\tI3204124\n\t00884450636695\tI3213949\n\t00884450636695\tI3232111\n\t00884450636695\tI3232118\n\t00884450636695\tI3232119\n\t00884450636695\tI3237621\n\t00884450636695\tI3237646\n\t00884450636695\tI3251181\n\t00884450636695\tI3251182\n\t00884450636695\tI3251183\n\t00884450636695\tI3251184\n\t00884450636695\tI3251185\n\t00884450636695\tI3251186\nIN4130/H\t00884450636695\tI2623447\n\t00884450636695\tI2639668\n\t00884450636695\tI2657810\n\t00884450636695\tI2663024\n\t00884450636695\tI2976522\n\t00884450636695\tI2989138\n\t00884450636695\tI3014317\n\t00884450636695\tI3014321\n\t00884450636695\tI3023697\n\t00884450636695\tI3098957\n\t00884450636695\tI3118231\n\t00884450636695\tI3161171\n\t00884450636695\tI3186059\n\t00884450636695\tI3204098\n\t00884450636695\tI3213970\n\t00884450636695\tI3213991\n\t00884450636695\tI3282764\nIN4130/JPH\t00884450636695\tI2563341\n\t00884450636695\tI2584111\n\t00884450636695\tI2593621\n\t00884450636695\tI2600945\n\t00884450636695\tI2617761\n\t00884450636695\tI2622049\n\t00884450636695\tI2648662\n\t00884450636695\tI2648663\n\t00884450636695\tI2812806\n\t00884450636695\tI2813127\n\t00884450636695\tI2819767\n\t00884450636695\tI2868572\n\t00884450636695\tI2887840\n\t00884450636695\tI2892034\n\t00884450636695\tI2917168\n\t00884450636695\tI2921906\n\t00884450636695\tI2927912\n\t00884450636695\tI2976523\n\t00884450636695\tI3001132\n\t00884450636695\tI3014322\n\t00884450636695\tI3023700\n\t00884450636695\tI3037358\n\t00884450636695\tI3074757\n\t00884450636695\tI3085670\n\t00884450636695\tI3098958\n\t00884450636695\tI3110563\n\t00884450636695\tI3146019\n\t00884450636695\tI3200761\n\t00884450636695\tI3213973\n\t00884450636695\tI3232041\n\t00884450636695\tI3262820\n\t00884450636695\tI3282766\nIN4130/K\t00884450637524\tI2719948\n\t00884450637524\tI2559561\n\t00884450637524\tI2572851\n\t00884450637524\tI2572852\n\t00884450637524\tI2617762\n\t00884450637524\tI2649063\n\t00884450637524\tI2649065\n\t00884450637524\tI2707737\n\t00884450637524\tI2714726\n\t00884450637524\tI2719962\n\t00884450637524\tI2748232\n\t00884450637524\tI2748233\n\t00884450637524\tI2748234\n\t00884450637524\tI2755246\n\t00884450637524\tI2759867\n\t00884450637524\tI2759868\n\t00884450637524\tI2759871\n\t00884450637524\tI2760566\n\t00884450637524\tI2770156\n\t00884450637524\tI2773967\n\t00884450637524\tI2773969\n\t00884450637524\tI2773970\n\t00884450637524\tI2784607\n\t00884450637524\tI2784608\n\t00884450637524\tI2853617\n\t00884450637524\tI2854185\n\t00884450637524\tI2858648\n\t00884450637524\tI2868573\n\t00884450637524\tI2868574\n\t00884450637524\tI2887838\n\t00884450637524\tI2887839\n\t00884450637524\tI2892035\n\t00884450637524\tI2903541\n\t00884450637524\tI2903542\n\t00884450637524\tI2917171\n\t00884450637524\tI2917172\n\t00884450637524\tI2918172S1\n\t00884450637524\tI2921907\n\t00884450637524\tI2921908\n\t00884450637524\tI2927913\n\t00884450637524\tI2933518\n\t00884450637524\tI2937696\n\t00884450637524\tI2937697\n\t00884450637524\tI2976524\n\t00884450637524\tI2988260S1\n\t00884450637524\tI2989139\n\t00884450637524\tI2989140\n\t00884450637524\tI2989141\n\t00884450637524\tI3001133\n\t00884450637524\tI3014325\n\t00884450637524\tI3014326\n\t00884450637524\tI3014327\n\t00884450637524\tI3014328\n\t00884450637524\tI3031136\n\t00884450637524\tI3031137\n\t00884450637524\tI3047976\n\t00884450637524\tI3048199\n\t00884450637524\tI3059081\n\t00884450637524\tI3074758\n\t00884450637524\tI3074759\n\t00884450637524\tI3084132\n\t00884450637524\tI3085671\n\t00884450637524\tI3097692\n\t00884450637524\tI3098960\n\t00884450637524\tI3118232\n\t00884450637524\tI3129665\n\t00884450637524\tI3129666\n\t00884450637524\tI3129667\n\t00884450637524\tI3150026\n\t00884450637524\tI3161172\n\t00884450637524\tI3161173\n\t00884450637524\tI3161174\n\t00884450637524\tI3182211\n\t00884450637524\tI3199105\n\t00884450637524\tI3199127\n\t00884450637524\tI3199131\n\t00884450637524\tI3204113\n\t00884450637524\tI3204114\n\t00884450637524\tI3204117\n\t00884450637524\tI3204121\n\t00884450637524\tI3204122\n\t00884450637524\tI3204123\n\t00884450637524\tI3232112\n\t00884450637524\tI3248089\n\t00884450637524\tI3262821\n\t00884450637524\tI3290570\n\t00884450637524\tI3290571\n\t00884450637524\tI3310655\n\t00884450637524\tI3310659\n\t00884450637524\tI3359468\nIN4130/KRK\t00884450751121\tI2917719\n\t00884450751121\tI2933519\n\t00884450751121\tI2976526\n\t00884450751121\tI3014329\n\t00884450751121\tI3056436\n\t00884450751121\tI3074760\n\t00884450751121\tI3119323\n\t00884450751121\tI3232075\nIN4130/L\t00884450638101\tI2593642\n\t00884450638101\tI2593643\n\t00884450638101\tI2593648\n\t00884450638101\tI2593649\n\t00884450638101\tI2628991\n\t00884450638101\tI2628993\n\t00884450638101\tI2639673\n\t00884450638101\tI2648667\n\t00884450638101\tI2657830\n\t00884450638101\tI2657831\n\t00884450638101\tI2669897\n\t00884450638101\tI2693439\n\t00884450638101\tI2693440\n\t00884450638101\tI2693441\n\t00884450638101\tI2703009\n\t00884450638101\tI2714727\n\t00884450638101\tI2755249\n\t00884450638101\tI2759872\n\t00884450638101\tI2759873\n\t00884450638101\tI2784624\n\t00884450638101\tI2812807\n\t00884450638101\tI2834503\n\t00884450638101\tI2839309\n\t00884450638101\tI2844308\n\t00884450638101\tI2853620\n\t00884450638101\tI2858643\n\t00884450638101\tI2868575\n\t00884450638101\tI2887843\n\t00884450638101\tI2887844\n\t00884450638101\tI2903545\n\t00884450638101\tI2921909\n\t00884450638101\tI2921910\n\t00884450638101\tI2927914\n\t00884450638101\tI2933520\n\t00884450638101\tI2933521\n\t00884450638101\tI2976527\n\t00884450638101\tI2989152\n\t00884450638101\tI2989153\n\t00884450638101\tI3001134\n\t00884450638101\tI3001135\n\t00884450638101\tI3014332\n\t00884450638101\tI3014333\n\t00884450638101\tI3014334\n\t00884450638101\tI3023701\n\t00884450638101\tI3023702\n\t00884450638101\tI3031138\n\t00884450638101\tI3048389\n\t00884450638101\tI3056437\n\t00884450638101\tI3056438\n\t00884450638101\tI3074761\n\t00884450638101\tI3074762\n\t00884450638101\tI3079097\n\t00884450638101\tI3079098\n\t00884450638101\tI3085672\n\t00884450638101\tI3098961\n\t00884450638101\tI3098962\n\t00884450638101\tI3098963\n\t00884450638101\tI3129669\n\t00884450638101\tI3200762\nIN4130/T\t00884450860953\tI3134851\n\t00884450860953\tI3161176\n\t00884450860953\tI3161177\n\t00884450860953\tI3186046\n\t00884450860953\tI3186049\n\t00884450860953\tI3204102\n\t00884450860953\tI3204110\n\t00884450860953\tI3213985\n\t00884450860953\tI3232042\n\t00884450860953\tI3248073\n\t00884450860953\tI3282771\n\t00884450860953\tI3282772\n\t00884450860953\tI3282773\n\t00884450860953\tI3290574\nIN4230/JPH\t00884450658963\tI2629020\n\t00884450658963\tI2657814\nIN4230/K\t00884450638316\tI2567486\n\t00884450638316\tI2593651\n\t00884450638316\tI2607305\n\t00884450638316\tI2617770\n\t00884450638316\tI2617771\n\t00884450638316\tI2639677\n\t00884450638316\tI2639678\n\t00884450638316\tI2648669\n\t00884450638316\tI2648670\n\t00884450638316\tI2648672\n\t00884450638316\tI2657809\n\t00884450638316\tI2657822\n\t00884450638316\tI2663022\n\t00884450638316\tI2669893\n\t00884450638316\tI2678047\n\t00884450638316\tI2684456\n\t00884450638316\tI2689145\n\t00884450638316\tI2714730\n\t00884450638316\tI2773990\n\t00884450638316\tI2784605\nIN4330/CNK\t00884450675120\tI2701204\n\t00884450675120\tI2752079\n\t00884450675120\tI2759877\n\t00884450675120\tI2989154\n\t00884450675120\tI3014337\n\t00884450675120\tI3014338\n\t00884450675120\tI3023703\n\t00884450675120\tI3031139\n\t00884450675120\tI3048391\n\t00884450675120\tI3186062\n\t00884450675120\tI3200763\n\t00884450675120\tI3204109\n\t00884450675120\tI3213942\nIN4330/K\t00884450638323\tI2535054\n\t00884450638323\tI2578105\n\t00884450638323\tI2593652\n\t00884450638323\tI2607445\n\t00884450638323\tI2617772\n\t00884450638323\tI2617773\n\t00884450638323\tI2617774\n\t00884450638323\tI2622051\n\t00884450638323\tI2622052\n\t00884450638323\tI2639680\n\t00884450638323\tI2794464\n\t00884450638323\tI2815171\n\t00884450638323\tI2827040\n\t00884450638323\tI2844309\n\t00884450638323\tI2866343\n\t00884450638323\tI2868576\n\t00884450638323\tI2868577\n\t00884450638323\tI2887845\n\t00884450638323\tI2887846\n\t00884450638323\tI2917174\n\t00884450638323\tI2921911\n\t00884450638323\tI2921912\n\t00884450638323\tI2933522\n\t00884450638323\tI2937698\n\t00884450638323\tI2937699\n\t00884450638323\tI2976528\n\t00884450638323\tI2989155\n\t00884450638323\tI2989156\n\t00884450638323\tI3014341\n\t00884450638323\tI3023704\n\t00884450638323\tI3023705\n\t00884450638323\tI3031141\n\t00884450638323\tI3031142\n\t00884450638323\tI3085673\n\t00884450638323\tI3098964\n\t00884450638323\tI3098965\n\t00884450638323\tI3098966\n\t00884450638323\tI3118234\n\t00884450638323\tI3118235\n\t00884450638323\tI3146023\n\t00884450638323\tI3161189\n\t00884450638323\tI3186045\n\t00884450638323\tI3186063\n\t00884450638323\tI3186066\n\t00884450638323\tI3213982\n\t00884450638323\tI3232104\n\t00884450638323\tI3232114\n\t00884450638323\tI3245232\n\t00884450638323\tI3251192\n\t00884450638323\tI3262822\n\t00884450638323\tI3262823\n\t00884450638323\tI3280486\nIN4352/K\t00884450638347\tI2519350\n\t00884450638347\tI2578108\n\t00884450638347\tI2584168\n\t00884450638347\tI2584169\n\t00884450638347\tI2593666\n\t00884450638347\tI2607447\n\t00884450638347\tI2617775\n\t00884450638347\tI2622053\n\t00884450638347\tI2622054\n\t00884450638347\tI2639669\n\t00884450638347\tI2639670\n\t00884450638347\tI2648675\n\t00884450638347\tI2657807\n\t00884450638347\tI2657808\n\t00884450638347\tI2663020\n\t00884450638347\tI2678046\n\t00884450638347\tI2684457\n\t00884450638347\tI2839305\n\t00884450638347\tI2853623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"firm_fei_number": "1721504", "recalling_firm": "Merit Medical Systems, Inc.", "address_1": "1600 W Merit Pkwy", "city": "South Jordan", "state": "UT", "postal_code": "84095-2416", "additional_info_contact": "Merit Customer Service\n1800-356-3748", "reason_for_recall": "Inflation device handle may detach from the syringe during procedure.", "root_cause_description": "Process control", "action": "On December 4, 2025 Merit Medical issued a \"Urgent Medical Device Recall Notice\" to affected consignees via E-Mail. Merit asked consignees to take the following actions:\n\n1. Please read and understand the recall notification. \n\n2. Should the handle detach during use and the balloon not completely deflate, pull the\nhandle out of the inflation syringe, disconnect the inflation syringe from the catheter, and use an alternate syringe to generate vacuum and aspirate residual contrast\n\n3. Ensure that applicable personnel within your organization are made aware of this field action.\n\n3. If the product has been further distributed to other facilities, institutions, or manufacturers, please\nensure this notice is immediately shared with them.\n\n4. Please fill out, scan, and email the completed Customer Response Form to Customer Service at RESPONSE@merit.com within seven (7) calendar days", "product_quantity": "4,163,123 units", "distribution_pattern": "Worldwide - Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY, St. Thomas , Puerto Rico and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Republic of Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Luxembourg, Madagascar, Mexico, Monaco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Trinidad and Tobago, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian, Republic of Viet Nam.", "openfda": { "registration_number": [ "2032677", "3034544377", "3012050423", "3011826338", "3005099803", "9681260", "3002807314", "3006750742", "3015225571", "3012494290", "3007800906", "3009613036", "3004837686", "1528319", "3016950436", "3019807891", "3006950086", "3012536737", "1721504", "3015309643", "1043729", "3010188783", "3011564431", "1000533027", "3013526170", "3010391265", "3010273872", "3011642792", "3013188547", "1724474", "3007835716", "3014390222", "3033773618", "3018182863", "9616684", "1721676", "2124215", "1047843", "3018312328", "3016931787", "3006223010", "3009605245", "1417592", "3004859241", "3033589330", "3019373845", "1000121056", "3013440400", "3000247873", "2030624", "9616662", "3007361214", "3012964172", "3005941719", "3045058049", "3008002401", "3005273623" ], "fei_number": [ "3034544377", "3002807111", "3012050423", "3011826338", "3005099803", "3003945344", "3003094851", "3002807314", "3006750742", "3000206435", "3015225571", "3012494290", "3007800906", "3009613036", "3004837686", "3019807891", "3016950436", "3006950086", "3012536737", "1721504", "3015309643", "1043729", "3010188783", "3011564431", "1000533027", "3013526170", "3010391265", "3010273872", "3011642792", "3013188547", "3007835716", "3014390222", "3033773618", "3018182863", "1721676", "2124215", "1047843", "3018312328", "3016931787", "3002806565", "3006223010", "3009605245", "1417592", "3004859241", "3033589330", "3019373845", "1000121056", "3002913962", "3013440400", "3000247873", "3007361214", "1000122656", "3012964172", "3045058049", "3000335778", "3008002401", "3005273623" ], "device_name": "Syringe, Balloon Inflation, Exempt", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1650", "device_class": "2" } } ] }