FDA Device Registration & Listing · Cankaya Ankara, TR · Registration 3014279513
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | General, Plastic Surgery | Class 2 | 878.3300 | 2025-04-30 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-04-09 |
| OQY | Intrauterine Tamponade Balloon | Obstetrics/Gynecology | Class 2 | 884.4530 | 2018-03-03 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2025-11-26 |
| GAN | Suture, Absorbable, Synthetic | General, Plastic Surgery | Class 2 | 878.4830 | 2018-03-03 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2018-03-03 |
| GDW | Staple, Implantable | General, Plastic Surgery | Class 2 | 878.4750 | 2025-08-24 |
| FTL | Mesh, Surgical, Polymeric | General, Plastic Surgery | Class 2 | 878.3300 | 2025-04-21 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2018-03-03 |
| LKF | Cannula, Manipulator/Injector, Uterine | Obstetrics/Gynecology | Class 2 | 884.4530 | 2018-03-03 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-04-08 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-04-08 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1720 | 2018-04-08 |
| OCW | Endoscopic Tissue Approximation Device | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-04-21 |
| GDW | Staple, Implantable | General, Plastic Surgery | Class 2 | 878.4750 | 2025-04-21 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2018-03-03 |
| HGI | Electrocautery, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.4120 | 2018-03-03 |
| LFL | Instrument, Ultrasonic Surgical | Unknown | Class U | N/A | 2018-03-03 |
| CEC | Radioimmunoassay, Free Thyroxine | Clinical Chemistry | Class 2 | 862.1695 | 2018-04-05 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | Clinical Chemistry | Class 2 | 862.1690 | 2018-04-05 |
| LFL | Instrument, Ultrasonic Surgical | Unknown | Class U | N/A | 2018-04-05 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-04-09 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-04-08 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Ear, Nose, Throat | Class 2 | 874.4250 | 2025-09-25 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | Gastroenterology, Urology | Class 2 | 876.5820 | 2018-04-08 |
| FTL | Mesh, Surgical, Polymeric | General, Plastic Surgery | Class 2 | 878.3300 | 2025-06-16 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-04-08 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-03-03 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2018-04-08 |
| FZP | Clip, Implantable | General, Plastic Surgery | Class 2 | 878.4300 | 2025-06-03 |
| JIT | Calibrator, Secondary | Clinical Chemistry | Class 2 | 862.1150 | 2018-04-08 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | Gastroenterology, Urology | Class 2 | 876.5860 | 2018-03-03 |
| LFL | Instrument, Ultrasonic Surgical | Unknown | Class U | N/A | 2018-03-03 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | Gastroenterology, Urology | Class 2 | 876.5860 | 2018-06-28 |
| GAG | Stapler, Surgical | General Hospital | Class 2 | 878.4740 | 2018-03-03 |
| GDW | Staple, Implantable | General, Plastic Surgery | Class 2 | 878.4750 | 2018-03-03 |
| ETN | Stimulator, Nerve | Ear, Nose, Throat | Class 2 | 874.1820 | 2018-04-12 |
| GAN | Suture, Absorbable, Synthetic | General, Plastic Surgery | Class 2 | 878.4830 | 2018-03-03 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | Class 1 | 862.1660 | 2018-04-08 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2018-03-03 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | General, Plastic Surgery | Class 2 | 878.5010 | 2018-03-03 |
| HIG | Insufflator, Hysteroscopic | Obstetrics/Gynecology | Class 2 | 884.1700 | 2018-04-08 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2025-04-21 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | Gastroenterology, Urology | Class 2 | 876.5860 | 2018-04-08 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2025-11-26 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-04-08 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2025-09-15 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | Class 1 | 862.1660 | 2018-04-05 |
| FZP | Clip, Implantable | General, Plastic Surgery | Class 2 | 878.4300 | 2018-02-23 |
| FIP | Subsystem, Water Purification | Gastroenterology, Urology | Class 2 | 876.5665 | 2018-04-08 |
| NTN | Led Light Source | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-04-08 |
| FCW | Light Source, Fiberoptic, Routine | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-04-08 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2018-03-03 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-04-08 |
| FEC | Obturator, For Endoscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-04-08 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | Gastroenterology, Urology | Class 2 | 876.4680 | 2018-04-08 |
| FGA | Kit, Nephroscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-04-08 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-04-24 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2025-07-28 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | Class 1 | 862.1660 | 2018-04-08 |
| FTL | Mesh, Surgical, Polymeric | General, Plastic Surgery | Class 2 | 878.3300 | 2018-04-11 |
| LKF | Cannula, Manipulator/Injector, Uterine | Obstetrics/Gynecology | Class 2 | 884.4530 | 2018-02-27 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | General, Plastic Surgery | Class 2 | 878.5010 | 2018-03-03 |
| LFL | Instrument, Ultrasonic Surgical | Unknown | Class U | N/A | 2018-03-03 |
| EZQ | Pouch, Colostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2018-04-08 |
| MOV | Catheters, Salpingography | Obstetrics/Gynecology | Class 2 | 884.4530 | 2018-03-03 |
| HBB | Motor, Drill, Pneumatic | Neurology | Class 2 | 882.4370 | 2026-06-09 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2018-04-05 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | Gastroenterology, Urology | Class 2 | 876.5820 | 2018-04-08 |
| FTL | Mesh, Surgical, Polymeric | General, Plastic Surgery | Class 2 | 878.3300 | 2018-05-17 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-04-08 |
| FTT | Camera, Still, Surgical | General, Plastic Surgery | Class 1 | 878.4160 | 2018-04-05 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2018-04-08 |
| GDO | Applier, Surgical, Clip | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-31 |
| FDP | Apparatus, Pneumoperitoneum, Automatic | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-03-03 |
| JIT | Calibrator, Secondary | Clinical Chemistry | Class 2 | 862.1150 | 2018-04-08 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | Class 1 | 862.1660 | 2018-04-05 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-04-24 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2018-03-03 |
| MTD | Catheter, Intracardiac Mapping, High-Density Array | Cardiovascular | Class 2 | 870.1220 | 2025-05-14 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | Class 1 | 862.1660 | 2018-04-08 |
| NTN | Led Light Source | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-04-08 |
| FCW | Light Source, Fiberoptic, Routine | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-04-08 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | Radiology | Class 2 | 892.1650 | 2018-02-23 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | Radiology | Class 2 | 892.1650 | 2018-02-23 |
| OWB | Interventional Fluoroscopic X-Ray System | Radiology | Class 2 | 892.1650 | 2018-02-23 |
| HIF | Insufflator, Laparoscopic | Obstetrics/Gynecology | Class 2 | 884.1730 | 2018-04-05 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2018-04-08 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2018-04-08 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2018-04-08 |
| FCG | Biopsy Needle | Gastroenterology, Urology | Class 2 | 876.1075 | 2018-03-03 |
| KNW | Instrument, Biopsy | Gastroenterology, Urology | Class 2 | 876.1075 | 2018-03-03 |
| GDW | Staple, Implantable | General, Plastic Surgery | Class 2 | 878.4750 | 2018-02-28 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1690 | 2018-04-08 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2018-04-08 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2018-04-08 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2018-04-08 |
| OCW | Endoscopic Tissue Approximation Device | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-04-30 |
| GDW | Staple, Implantable | General, Plastic Surgery | Class 2 | 878.4750 | 2018-06-28 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1690 | 2018-04-08 |
| FGC | Urethroscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-04-08 |
| FBP | Telescope, Rigid, Endoscopic | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-04-08 |
| BTR | Tube, Tracheal (W/Wo Connector) | Anesthesiology | Class 2 | 868.5730 | 2018-02-23 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K220540 | Covidien | ProGrip Self-Gripping Polypropylene Mesh | 2022-09-22 |
| K062348 | Medtronic Neurosurgery | TIMESH SELF DRILLING SCREW | 2006-09-08 |
| K063244 | Arc Surgical, LLC | ARC SURGICAL BONE REDUCTION SCREW | 2006-12-27 |
| K972722 | Orthopedic Designs, Inc. | ULTIMATE COMPRESSION SCREW SYSTEM | 1998-01-23 |
| K192974 | Tyber Medical, LLC | Tyber Medical Trauma Screw | 2020-01-08 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0014-2014 | Synthes USA HQ, Inc. | 2 | Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle. |
| Z-0026-2013 | Orthohelix Surgical Designs Inc | 2 | OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS
The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle. |
| Z-0026-2016 | Ortho Solutions Inc 330 Franklin Tnpk | 2 | Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile
Orthopaedic Bone Screw |
| Z-0027-2013 | Orthohelix Surgical Designs Inc | 2 | OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS
The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle. |
| Z-0043-2018 | MicroPort Orthopedics Inc. | 2 | MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R
Product Usage:
MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3005619880 | Boston Scientific Corporation | Roswell, GA, US |
| 1213643 | DAVOL INC., SUB. C.R. BARD, INC. | Warwick, RI, US |
| 8020712 | LOCKDOWN MEDICAL LIMITED | Redditch Worcestershire, GB |
| 1061124 | Sterigenics U.S., LLC | Charlotte, NC, US |
| 3009514842 | NOVUS SCIENTIFIC INC | Wrentham, MA, US |
3014279513 when referencing this establishment in official correspondence.