{ "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": "2026-10-19", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "proprietary_name": [ "Canulated Drill", "Blade insert dia 64 short endoCupcut", "Extraction Bolt for 5 / 6.5 / 7 mm Screw", "Slot mallet endoCupex", "Handpiece OrthoClast", "VHM Twist drill for titanium Dia6 mm Cutting direction right", "Extractor T-handle", "Valve cartridge, multiple use (5 pcs)", "RevisioLine Chisel Blade 60/8 mm", "Suction sheath", "Compressed Air Hose Wall Plug Adapter DeltaP Air800 ISO9170-1 - Rectus NW 7,2", "RevisioLine Chisel Blade 60/6 mm SINGLE USE", "Pincers 25 cm parallel to the axis", "Centrical Bolt used with Hollow Reamer for 1.5 mm", "Hollow cutter Set Dia12-18 mm", "Mini Lexer Gouge length 4 mm 18 cm", "RevisioLine chisel blade 8 mm curved R SINGLE USE", "VHM Twist drill for titanium Dia4 mm Cutting direction right", "Compressed air hose Rectus wallside / Synthes /AO with diffuser", "Conical extraction screw", "System tray for EndoDriver", "Compressed air hose Draeger Air-Motor - Synthes/AO blue 5 m", "Quick coupling t-handle", "Hollow cutter diameter Dia17 mm", "System tray endoCupcut", "Hollow Reamer for 5 / 6.5 / 7 mm Screws", "Cap Nut", "Compressed air hose adapter NIST Air800 - Rectus NW 7.2", "Twist drill for titanium Dia6.5 mm Cutting direction right", "Compressed Air Hose Wall Plug Swedish Standard Air - Rectus NW 7,2", "Short blade insert - small set endoCupcut", "O-Rings flushing attachment", "short negative hollow tip dia. 4 mm, 200 mm", "Blade insert dia 56 short endoCupcut", "StemExtractor AE2 ABC 02 Instrument", "Blade insert dia 48 large endoCupcut", "Open-end spanner (GG shape) 19x22 width across flats 19x22mm", "Twist drill for titanium Dia5.5 mm Cutting direction right", "Compressed air hose Swedish Std. -- Synthes/AO, 50 m, green", "Cone endoCupex", "OrthoClast 2 Module 1 - Basic Set", "Ball heads dia 44 endoCupcut", "Ball heads dia 42 endoCupcut", "RevisioLine Chisel Blade 60/12 mm SINGLE USE", "Lever StemExtractor", "Open-end wrench SW9", "Compressed Air Hose Adapter Schrader / Hall-coupling, 5 m, blue", "Compressed Air Hose Aesculap - Synthes/AO-coupling, 0.3m length, green", "Blade insert dia 72 short endoCupcut", "Twist drill for titanium Dia3 mm Cutting direction right", "RevisioLine Chisel Blade 190/6 mm", "RevisioLine set complete", "RevisioLine Chisel Blade 60/8 mm SINGLE USE", "Deschamps Ligature Needle 40 max. 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Synthes/AO blue 5m with Diffusor", "Ball heads dia 38 endoCupcut", "Handle with support endoCupcut", "Tray insert for endoCupex", "RevisioLine chisel blade 8 mm curved R", "Thread main cutter HAND M 6x0.75 HSS", "Blade insert dia 52 large endoCupcut", "Spare Reamer (Reamer Tube) for Hollow Reamer 1.5 mm", "Chisel FR-057 - chisel long positive gouge tip, curved", "Blade insert dia 48 short endoCupcut", "Hollow reamer for orthopaedic surgery AD Dia10 mm Operating depth 130mm", "Hollow cutter diameter Dia12 mm", "Foot pedal grey", "Locking pliers set", "Compressed Air Hose Wall Plug Adapter Rectus NW 5 (klein) / Dental - Rectus NW 7,2", "Pincers 30 cm with hammer 700 g parallel to the axis", "Centrical Bolt used with Hollow Reamer for 2 mm", "Compression bolt with plastic insert StemExtractor", "Ball heads dia 54 endoCupcut", "Compressed Air Hose Wall Plug Adapter Industry Standard France/Spain - Rectus NW 7,2", "Foot pedal", "Extraction Bolt for 3.5 / 4 mm Screws", "Extraction Bolt for 2.7 mm Screws", "Ball heads dia 50 endoCupcut", "RevisioLine Chisel Blade 60/25 mm", "Head of tool AE StemExtractor", "Compressed Air Hose Wall Plug Adapter AFNOR 7mm - Rectus NW 7,2", "Driver hexagonal sw 2,5mm", "Compressed air hose handpiece EL-147 for OrthoClast2 FT-200", "Blade insert dia 58 short endoCupcut", "Air pressure hose 4-kant wallside / Synthes /AO co", "Kirschner's wire 400 mm", "Sterilisation tray OrthoScope", "Compressed Air Hose Wall Plug Adapter Swedish Std Air - Synthes/AO, with exhaust air", "Pin punch Dia3.5", "Drill guide wire 400 mm dia. 2.5 mm", "Twist drill for titanium Dia7 mm Cutting direction right", "Flexible microstructure chisel -single use- 190mm - 7 mm", "Adapter for nail extractor size 2: 9-12mm", "Flexible microstructure chisel -single use- 160mm - 7mm", "Hollow Reamer for 2 mm Screws", "Screw Holding Forceps length 20,5 cm / 8“", "Ball head dia 40 endoCupcut", "Compressed Air Hose Aesculap - Synthes/AO-coupling, 0.3 m, black", "Compressed air hose MEDAP - Synthes/A0 green 5 m with diffuser", "RevisioLine Chisel Blade 60/10 mm SINGLE USE", "Blade insert dia 50 short endoCupcut", "Spare Reamer (Reamer Tube) for Hollow Reamer 5/6.5/7 mm", "Compressed Air Hose Adapter Schrader / Hall-coupling, 5 m, black", "Air pressure hose 4-kant - 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chisel screwdriver tip", "System tray endoCupcut Auxiliary advanced/professional", "Compressed Air Hose Wall Plug Adapter Swedish Standard Air - Rectus NW 7,2", "Screwdriver tip hollow dia. 4 mm, 270 mm", "RevisioLine Chisel Blade 125/6 mm", "Pressure rod L long StemExtractor", "VHM Twist drill for titanium Dia7.2 mm Cutting direction right", "OrthoClast - Module 2 for Cement Removal", "Blade insert dia 46 large endoCupcut", "Compressed Air Hose Adapter Synthes / AO-coupling, 5 m, green", "Sterilisation tray handpiece", "Screwdriver with guide pin", "endoCupcut set professional", "Short blade insert - large set endoCupcut", "Steritray for HIP Stem Extractor S2", "Compressed air hose Draeger Air-Motor - Synthes/AO 5 m, green", "Adapter for nail extractor size 3: 12-15mm", "Blade insert dia 70 large endoCupcut", "LegholderRX standard", "Standard flushing valve", "Ball head attachment safeConnect", "Handle for Pneumatic Extractor PN with Feed Housing", "LegholderRX fusion", "RevisioLine Chisel Blade 190/6 mm SINGLE USE", "short negative hollow tip dia. 3,2 mm, 270 mm", "Split mallet OrthoClast", "RevisioLine Chisel Blade 190/8 mm", "endoCupcut advanced", "Guiding tube XL long StemExtractor", "Mini Lexer Gouge length 10 mm 18 cm", "Strike plate for RevisioLine handle 50mm", "Socket wrench size 6", "SteriTray OrthoScope", "RevisioLine handpiece for chisels", "Head of tool S2 StemExtractor", "Hexalobular Blade T25", "RevisioLine chisel blade 8 mm curved L SINGLE USE", "Tray insert endoCupcut advanced/professional", "OrthoClast2 control unit 230V", "Extraction tool set", "Allen key StemExtractor", "Compressed air hose Schrader - Hall light green 5m", "Set of tube adaptators (4 pieces)", "Aluminum contents template", "Sterilization tray nail extractor", "Hollow cutter diameter Dia15 mm", "Blade insert dia 66 large endoCupcut", "Extraction Bolt for 1.5 mm Screws", "Open-end spanner (GG shape) 12x13 width across flats 12x13mm", "Hollow reamer for orthopaedic surgery AD Dia8 mm Operating depth 130mm", "Chisel FR-052 - chisel short negative gouge tip, curved", "Chisel FR-054 - chisel hollow screwdriver tip", "Needle nosed locking plier 30 cm 3-sided", "Strike Plate", "StemExtractor instrument STANDARD S2", "Needle nosed locking plier 30 cm", "Osteotome for cup revision with silicone handle - L", "Deschamps Ligature Needle 60 max. Dia2mm", "Blade insert dia 56 large endoCupcut", "Steritray for HIP Stem Extractor universal", "endoCupcut essential", "RevisioLine Chisel Blade 125/4 mm", "Slide hammer weight 2.6 kg hip StemExtractor", "Chisel FR-058 - chisel long negative gouge tip, curved", "Compressed Air Hose Wall Plug Adapter NIST Air800 - Rectus NW 7,2", "Blade insert dia 54 short endoCupcut", "Pressure rod ST standard StemExtractor", "Silicone mat 245x245 mm blue", "Flexible microstructure chisel -single use- 160mm - 5 mm thin", "Set Drill and tap for titanium", "Blade insert dia 46 short endoCupcut", "Hexalobular Blade T40", "Compressed Air Hose Wall Plug Adapter Synthes/AO/ARO - Rectus NW 7,2", "Locking pliers 24 cm", "srewdriver tip dia. 3,2 mm, 270 mm", "Pincers 22 cm parallel to the axis", "Centrical Bolt used with Hollow Reamer for 2.7 mm", "endoCupex complete instrument - without tray", "long neg. hollow tip dia. 3.2 mm, 270 mm", "Osteotome for cup revision with silicone handle - M", "StemExtractor LONG - professional set", "Spanner StemExtractor", "hand piece holder", "Blade insert dia 72 large endoCupcut", "Spare Reamer (Reamer Tube) for Hollow Reamer 2.7 mm", "SET Deschamps Ligature Needles 40 - 50 - 60 - 70", "Blade insert dia 68 short endoCupcut", "Handpiece Tube", "Blade insert dia 44 short endoCupcut", "Mains plug US", "Deschamps Ligature Needle 50 max. Dia2mm", "Blade insert dia 54 large endoCupcut", "Head of tool AU/AU2 StemExtractor", "Centrical Bolt used with Hollow Reamer for 3.5 / 4 mm", "Draeger AIR-Motor air hose - Synthes/AO BLUE 5m", "Blade insert dia 58 large endoCupcut", "Blade insert dia 64 large endoCupcut", "Locking pliers 20 cm 3-sided", "Set of ball heads for surface replacement", "Ball heads dia 48 endoCupcut", "Driver hexagonal sw 3,5mm", "Nut for strike plate 1001.2.26", "StemExtractor instrument LONG", "LegholderRX extra stable", "Hook endoCupex", "Compressed Air Hose Adapter Synthes / AO-coupling, 5 m, blue", "Thread pre-cutter HAND M 6x0.75 HSS", "RevisioLine Chisel Blade 125/4 mm SINGLE USE", "Conical Extraction Screw for 4.5 / 5 / 6.5 / 7 mm Screws", "Tube connection hand piece OrthoClast 2 FT-200", "short negative hollow tip dia. 4 mm, 270 mm", "Locking pliers 20 cm with hammer 400 g parallel to the axis", "Sliding spacer U StemExtractor", "Conical Extraction Screw for 2.7 / 3.5 / 4 mm Screws", "Ball heads dia 60 endoCupcut", "hand piece OrthoClast 2", "Hollow reamer for orthopaedic surgery AD Dia10 mm Operating depth 100mm", "Hollow Reamer for 3.5 / 4 mm Screws", "Handle endoCupex", "Slotted hammer", "Hollow reamer for orthopaedic surgery AD Dia12 mm Operating depth 130mm", "Chisel FR-051 - chisel short negative gouge tip", "Compressed Air Hose, BS - Hall, 30m, green", "Chisel microstructure set", "LegholderRX short velcro straps 128 (paarweise)", "Compressed Air Hose Wall Plug Industry Std. France/Spain - Rectus NW 7,2", "Chisel set - Cement removal", "Wrench R11 StemExtractor", "Hollow Reamer for 2.7 mm Screws", "Blade insert dia 60 large endoCupcut", "Compressed air hose - BS--Synthes/AO BLUE 5 m with diffuser", "Power Supply Cable C13 3m", "Extraction sleeve", "OrthoClast control unit 230V", "System tray for endoCupex", "Jamcase PN StemExtractor", "Ceramic-inlay tappet safeConnect", "Blade insert dia 44 large endoCupcut", "Head of tool SA2 StemExtractor", "Adapter for nail extractor size 1.5", "StemExtractor instrument STANDARD AU", "Flexible microstructure chisel -single use- 160mm - 7mm", "Spare Reamer (Reamer Tube) for Hollow Reamer 3.5 / 4 mm", "VHM Twist drill for titanium Dia5 mm Cutting direction right", "Jamcase CC", "Ball head dia 28mm steel endoCupcut", "Compression spring", "Blade insert dia 70 short endoCupcut", "long positive hollow tip dia. 3,2 mm, 270 mm", "chisel long pos. gouge tip, curved dia. 4 /270mm", "Blade insert dia 62 large endoCupcut", "Compressed Air Hose Wall Plug Rectus NW 5 (smal)/Dental - Rectus NW 7,2", "Hollow Reamer for 1.5 mm Screws", "Handpiece holder", "Ball head dia 36mm steel endoCupcut", "Suction catheter CH10 2 lateral eyes", "Pointed-nose pliers 22cm 3-side connector", "Spare Reamer (Reamer Tube) for Hollow Reamer 4.5 mm", "StemExtractor instrument STANDARD-AU-S2", "Valve cartridge, sterile, single use", "Sharp Hook length 155 mm", "Compressed Air Hose Wall Plug Adapter AFNOR Air800 - Rectus NW 7,2", "Pointed-nose pliers 25 cm 3-side connector", "Handle ST2 StemExtractor", "Compressed air hose Rectus - ARO DN 5.5 (Synthes/AO)", "Medullary nail extractor main instrument", "Pin screw StemExtractor", "Disassembling handle endoCupcut complete", "Chisel FR-053 - chisel long positive gouge tip", "Locking pliers 20 cm", "Driver hexagonal sw 4,0mm", "Attachment Inlay Dia36 mm safeConnect", "Chisel FR-048 - chisel „short negative gouge tip”", "Forcep for bone plier, reusable", "Thread pre-cutter HAND M 8x0.75 HSS", "Air pressure hose Rectus wallside / Synthes /AO with diffuser", "OrthoClast 2 base unit", "Pressure rod XL long StemExtractor", "Strike plate for RevisioLine handle 60mm", "Deschamps Ligature Needle 70 max. Dia2mm", "Attachment Inlay Dia28 mm safeConnect", "Driver hexagonal sw 3,0mm", "SOS Screw-Extraction-Set complete", "Compressed Air Hose Wall Plug Adapter UNI 9507 Air800 - Rectus NW 7,2", "Intramedullary nail extractor complete", "Air hose without adapter - Synthes/AO light green 5m", "Draeger AIR-Motor air hose", "Hollow reamer for orthopaedic surgery AD Dia8 mm Operating depth 100 mm", "Locking pliers 24 cm with hammer 700 g parallel to the axis", "Hollow cutter diameter Dia13 mm" ], "establishment_type": [ "Manufacture Medical Device" ], "registration": { "registration_number": "3042243169", "fei_number": "3042243169", "status_code": "1", "initial_importer_flag": "N", "reg_expiry_date_year": "2027", "name": "ENDOCON GMBH", "address_line_1": "In der Au 5", "address_line_2": "", "city": "Wiesenbach Baden-Wurttemberg", "state_code": "", "iso_country_code": "DE", "zip_code": "", "postal_code": "69257", "us_agent": { "name": "Stephan Toupin", "business_name": "Dawa Medical LLC", "bus_phone_area_code": "305", "bus_phone_num": "5999373", "bus_phone_extn": "", "fax_area_code": "305", "fax_num": "6990557", "email_address": "stoupin@dawamedical.com", "address_line_1": "7320 Nw 12th St Ste 103", "address_line_2": "", "city": "Miami", "state_code": "FL", "iso_country_code": "US", "zip_code": "33126", "postal_code": "" }, "owner_operator": { "firm_name": "endocon GmbH", "owner_operator_number": "10094311", "official_correspondent": { "first_name": "Klaus", "middle_initial": "", "last_name": "Notarbartolo", "subaccount_company_name": "", "phone_number": "49-622-3739010-x" }, "contact_address": { "address_1": "In der Au 5", "address_2": "", "city": "Wiesenbach", "state_code": "DE-BW", "state_province": "Baden-Wurttemberg", "iso_country_code": "DE", "postal_code": "69257" } } }, "pma_number": "", "k_number": "", "products": [ { "product_code": "HSZ", "created_date": "2025-11-23", "owner_operator_number": "10094311", "exempt": "", "openfda": { "device_name": "Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4820", "device_class": "1" } } ] } ] }