FDA Device Registration & Listing · Rotterdam-Albrandswaard Zuid-Holland, NL · Registration 3016678045
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| GAB | Needle, Suturing, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2022-02-15 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2022-02-15 |
| GFD | Dermatome | General, Plastic Surgery | Class 1 | 878.4820 | 2022-11-02 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | Class 2 | 868.1400 | 2020-01-15 |
| FXY | Hood, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2024-12-04 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2024-12-04 |
| FCG | Biopsy Needle | Gastroenterology, Urology | Class 2 | 876.1075 | 2024-01-17 |
| FSH | Tray, Surgical, Needle | General, Plastic Surgery | Class 1 | 878.4800 | 2024-01-17 |
| LKF | Cannula, Manipulator/Injector, Uterine | Obstetrics/Gynecology | Class 2 | 884.4530 | 2026-01-23 |
| BYP | Mouthpiece, Breathing | Anesthesiology | Class 1 | 868.5620 | 2020-01-15 |
| FER | Anoscope And Accessories | Gastroenterology, Urology | Class 2 | 876.1500 | 2026-01-23 |
| FHN | Ligator, Hemorrhoidal | Gastroenterology, Urology | Class 2 | 876.4400 | 2026-01-23 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2025-08-20 |
| IKD | Cable, Electrode | Physical Medicine | Class 2 | 890.1175 | 2026-03-02 |
| EQJ | Bur, Ear, Nose And Throat | Ear, Nose, Throat | Class 1 | 874.4140 | 2021-06-01 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2023-01-03 |
| KCY | Tourniquet, Pneumatic | General, Plastic Surgery | Class 1 | 878.5910 | 2023-05-17 |
| FRC | Indicator, Biological Sterilization Process | General Hospital | Class 2 | 880.2800 | 2015-07-17 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2020-02-10 |
| LWK | Razor, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2015-07-21 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2022-09-26 |
| GBO | Catheter, Nephrostomy, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4200 | 2024-12-30 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2022-11-30 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2023-09-14 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2014-03-14 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | Anesthesiology | Class 2 | 868.5800 | 2014-03-14 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-07-23 |
| HIF | Insufflator, Laparoscopic | Obstetrics/Gynecology | Class 2 | 884.1730 | 2024-05-22 |
| OSV | Insufflator, Endoscopic Vessel Harvesting | Obstetrics/Gynecology | Class 2 | 884.1730 | 2024-05-22 |
| JOH | Tube Tracheostomy And Tube Cuff | Anesthesiology | Class 2 | 868.5800 | 2017-04-03 |
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | Class 2 | 870.1200 | 2025-08-06 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | Neurology | Class 2 | 882.4310 | 2023-09-20 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2015-07-20 |
| EQJ | Bur, Ear, Nose And Throat | Ear, Nose, Throat | Class 1 | 874.4140 | 2022-01-25 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | Neurology | Class 2 | 882.4310 | 2022-01-25 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2020-03-02 |
| NRY | Catheter, Thrombus Retriever | Cardiovascular | Class 2 | 870.1250 | 2023-02-04 |
| PAH | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling | General, Plastic Surgery | Class 2 | 878.3300 | 2023-04-04 |
| MNL | Accessories, Cleaning Brushes, For Endoscope | Gastroenterology, Urology | Class 1 | 876.1500 | 2025-01-17 |
| DQK | Computer, Diagnostic, Programmable | Cardiovascular | Class 2 | 870.1425 | 2024-11-11 |
| MTD | Catheter, Intracardiac Mapping, High-Density Array | Cardiovascular | Class 2 | 870.1220 | 2024-11-11 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | Class 2 | 870.1220 | 2024-11-11 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2022-02-28 |
| NBH | Accessories, Arthroscopic | Orthopedic | Class 1 | 888.1100 | 2024-02-15 |
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | Class 1 | 878.4018 | 2026-05-17 |
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | General, Plastic Surgery | Class 2 | 878.3300 | 2020-09-21 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2022-01-25 |
| FQM | Bandage, Elastic | General Hospital | Class 1 | 880.5075 | 2023-09-14 |
| FMQ | Restraint, Protective | General Hospital | Class 1 | 880.6760 | 2017-04-05 |
| GFF | Bur, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4820 | 2021-06-01 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | General, Plastic Surgery | Class 1 | 878.4820 | 2021-06-01 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2023-05-04 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2024-12-02 |
| FZP | Clip, Implantable | General, Plastic Surgery | Class 2 | 878.4300 | 2019-03-25 |
| HIF | Insufflator, Laparoscopic | Obstetrics/Gynecology | Class 2 | 884.1730 | 2024-05-22 |
| OSV | Insufflator, Endoscopic Vessel Harvesting | Obstetrics/Gynecology | Class 2 | 884.1730 | 2024-05-22 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2020-01-14 |
| ERA | Otoscope | Ear, Nose, Throat | Class 1 | 874.4770 | 2021-12-10 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2020-03-11 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1690 | 2026-01-23 |
| DQA | Oximeter | Cardiovascular | Class 2 | 870.2700 | 2020-07-22 |
| JKS | Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide | Clinical Toxicology | Class 1 | 862.3220 | 2020-07-22 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Cardiovascular | Class 2 | 870.2900 | 2020-07-22 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | Class 2 | 880.2800 | 2015-07-21 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2026-06-08 |
| GXI | Probe, Radiofrequency Lesion | Neurology | Class 2 | 882.4725 | 2025-04-01 |
| GXD | Generator, Lesion, Radiofrequency | Neurology | Class 2 | 882.4400 | 2026-01-23 |
| GXI | Probe, Radiofrequency Lesion | Neurology | Class 2 | 882.4725 | 2026-01-23 |
| NIQ | Coronary Drug-Eluting Stent | Unknown | Class 3 | N/A | 2023-01-03 |
| GDO | Applier, Surgical, Clip | General, Plastic Surgery | Class 1 | 878.4800 | 2022-12-08 |
| HBO | Clip, Scalp | Neurology | Class 2 | 882.4150 | 2022-12-08 |
| DRX | Electrode, Electrocardiograph | Cardiovascular | Class 2 | 870.2360 | 2015-07-21 |
| FTL | Mesh, Surgical, Polymeric | General, Plastic Surgery | Class 2 | 878.3300 | 2024-12-02 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2019-09-06 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | Class 2 | 870.1220 | 2024-12-02 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2020-01-15 |
| LKF | Cannula, Manipulator/Injector, Uterine | Obstetrics/Gynecology | Class 2 | 884.4530 | 2025-06-27 |
| HIG | Insufflator, Hysteroscopic | Obstetrics/Gynecology | Class 2 | 884.1700 | 2025-02-07 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2023-01-03 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2020-12-22 |
| EWD | Protector, Hearing (Insert) | Unknown | Class U | N/A | 2015-07-21 |
| FRG | Wrap, Sterilization | General Hospital | Class 2 | 880.6850 | 2017-04-05 |
| NVY | Permanent Defibrillator Electrodes | Unknown | Class 3 | N/A | 2023-04-04 |
| NVN | Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | Unknown | Class 3 | N/A | 2023-04-04 |
| DTB | Permanent Pacemaker Electrode | Cardiovascular | Class 3 | 870.3680 | 2023-04-04 |
| MDB | System, Blood Culturing | Microbiology | Class 1 | 866.2560 | 2024-08-20 |
| HQB | Photocoagulator And Accessories | Ophthalmic | Class 2 | 886.4690 | 2023-05-17 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | Class 2 | 874.4680 | 2024-12-18 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | Ear, Nose, Throat | Class 2 | 874.4760 | 2024-12-18 |
| NWB | Endoscope, Accessories, Narrow Band Spectrum | Gastroenterology, Urology | Class 2 | 876.1500 | 2024-12-18 |
| KGW | Ring (Wound Protector), Drape Retention, Internal | General, Plastic Surgery | Class 2 | 878.4370 | 2019-07-22 |
| PUI | Drape, Surgical, Exempt | General, Plastic Surgery | Class 2 | 878.4370 | 2026-05-17 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-06-27 |
| EMX | Balloon, Epistaxis | Ear, Nose, Throat | Class 1 | 874.4100 | 2020-01-15 |
| ORQ | Mesh, Surgical, Deployer | General, Plastic Surgery | Class 2 | 878.3300 | 2022-01-25 |
| JDZ | Mixer, Cement, For Clinical Use | Orthopedic | Class 1 | 888.4210 | 2025-02-27 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2021-04-21 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Orthopedic | Class 2 | 888.3030 | 2021-04-21 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2021-04-21 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2015-07-20 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2015-07-21 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2022-02-28 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2025-01-17 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | Cardiovascular | Class 2 | 870.5100 | 2023-04-04 |
| KNW | Instrument, Biopsy | Gastroenterology, Urology | Class 2 | 876.1075 | 2025-04-16 |
| GDW | Staple, Implantable | General, Plastic Surgery | Class 2 | 878.4750 | 2020-05-20 |
| DRX | Electrode, Electrocardiograph | Cardiovascular | Class 2 | 870.2360 | 2023-12-18 |
| FTL | Mesh, Surgical, Polymeric | General, Plastic Surgery | Class 2 | 878.3300 | 2022-01-25 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2020-01-15 |
| FYC | Gown, Isolation, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2017-04-05 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2019-09-26 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2021-06-18 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | Class 2 | 880.2800 | 2015-07-21 |
| FYD | Apparatus, Exhaust, Surgical | General, Plastic Surgery | Class 2 | 878.5070 | 2022-11-30 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | General, Plastic Surgery | Class 2 | 878.4780 | 2022-11-30 |
| KAP | Curette, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2026-05-17 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2023-04-04 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2022-02-28 |
| HIF | Insufflator, Laparoscopic | Obstetrics/Gynecology | Class 2 | 884.1730 | 2020-01-14 |
| EXB | Collector, Ostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2014-06-02 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2021-10-28 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2022-09-13 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2019-07-22 |
| MSH | Respirator, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2015-07-20 |
| LQR | Dislodger, Stone, Biliary | Gastroenterology, Urology | Class 2 | 876.5010 | 2023-01-03 |
| FYD | Apparatus, Exhaust, Surgical | General, Plastic Surgery | Class 2 | 878.5070 | 2024-07-08 |
| KMF | Bandage, Liquid | General Hospital | Class 1 | 880.5090 | 2015-07-21 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2020-02-10 |
| FTL | Mesh, Surgical, Polymeric | General, Plastic Surgery | Class 2 | 878.3300 | 2024-12-02 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2023-03-21 |
| ERA | Otoscope | Ear, Nose, Throat | Class 1 | 874.4770 | 2021-12-10 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2020-01-15 |
| CCW | Laryngoscope, Rigid | Anesthesiology | Class 1 | 868.5540 | 2021-12-10 |
| HIF | Insufflator, Laparoscopic | Obstetrics/Gynecology | Class 2 | 884.1730 | 2025-04-04 |
| ETN | Stimulator, Nerve | Ear, Nose, Throat | Class 2 | 874.1820 | 2022-01-24 |
| HQF | Laser, Ophthalmic | Ophthalmic | Class 2 | 886.4390 | 2023-05-17 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | Class 2 | 878.4810 | 2023-05-17 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | Class 2 | 870.1220 | 2021-02-19 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Ophthalmic | Class 1 | 886.4750 | 2020-01-15 |
| LOD | Bone Cement | Orthopedic | Class 2 | 888.3027 | 2020-01-15 |
| NEU | Marker, Radiographic, Implantable | General, Plastic Surgery | Class 2 | 878.4300 | 2025-04-16 |
| GDW | Staple, Implantable | General, Plastic Surgery | Class 2 | 878.4750 | 2020-01-13 |
| FZP | Clip, Implantable | General, Plastic Surgery | Class 2 | 878.4300 | 2023-08-10 |
| DTE | Pulse-Generator, Pacemaker, External | Cardiovascular | Class 2 | 870.3600 | 2023-04-04 |
| KQZ | Component, Traction, Non-Invasive | Orthopedic | Class 1 | 888.5890 | 2024-09-27 |
| ETD | Tube, Tympanostomy | Ear, Nose, Throat | Class 2 | 874.3880 | 2020-01-14 |
| LLZ | System, Image Processing, Radiological | Radiology | Class 2 | 892.2050 | 2019-01-28 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2019-01-28 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2019-01-28 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2023-01-03 |
| FQH | Lavage, Jet | General Hospital | Class 2 | 880.5475 | 2020-12-22 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | Gastroenterology, Urology | Class 2 | 876.5860 | 2024-08-20 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K914997 | Conmedcorp | ASP-IRRATOR | 1992-01-07 |
| K153773 | Olympus Medical Systems Corp. | Disposal Lens Cleaning Sheath | 2016-11-22 |
| K940141 | Micro-Medical Devices, Inc. | LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH | 1994-05-19 |
| K933812 | Advanced Surgical, Inc. | ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES | 1993-12-13 |
| K254228 | Karl Storz SE & CO. KG | KARL STORZ Trocars with Valve Seals | 2026-05-11 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0027-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures. |
| Z-0028-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures. |
| Z-0029-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled
(2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures. |
| Z-0021-2019 | Oridion Medical 1987 Ltd. Har Hotzvim Industrial | 2 | CAPNOSTREAM 20P (US) N, Part Number CS08651-01 |
| Z-0024-2019 | Oridion Medical 1987 Ltd. Har Hotzvim Industrial | 2 | CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3027516563 | STAR SPORTS MEDICINE CO., LTD. | Beijing, CN |
| 3015131017 | FIELD ORTHOPAEDICS | Teneriffe Queensland, AU |
| 9610612 | AESCULAP AG | TUTTLINGEN, DONAU Baden-Wurttemberg, DE |
| 3008392711 | ANQING KANGMINGNA PACKAGING CO.,LTD | Anqing Anhui, CN |
| 3010331645 | Arthrex, Inc. | Ave Maria, FL, US |
3016678045 when referencing this establishment in official correspondence.