FDA Device Registration & Listing · RICHMOND, VA, US · Registration 1123137
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| JCT | Prosthesis, Tracheal, Expandable | General, Plastic Surgery | Class 2 | 878.3720 | 2020-03-03 |
| MNL | Accessories, Cleaning Brushes, For Endoscope | Gastroenterology, Urology | Class 1 | 876.1500 | 2019-11-06 |
| GCC | Dilator, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2020-03-24 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2020-02-27 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2020-02-27 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2020-02-27 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2020-03-24 |
| JCT | Prosthesis, Tracheal, Expandable | General, Plastic Surgery | Class 2 | 878.3720 | 2020-03-03 |
| DXT | Injector And Syringe, Angiographic | Cardiovascular | Class 2 | 870.1650 | 2012-12-04 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2020-03-03 |
| OKV | Obstetrical Kit | Obstetrics/Gynecology | Class 2 | 884.4520 | 2015-07-09 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2020-03-10 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2012-11-21 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2020-03-24 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2020-03-20 |
| KIT | Media And Components, Synthetic Cell And Tissue Culture | Hematology | Class 1 | 864.2220 | 2012-11-21 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2012-11-26 |
| JCT | Prosthesis, Tracheal, Expandable | General, Plastic Surgery | Class 2 | 878.3720 | 2020-03-03 |
| DXT | Injector And Syringe, Angiographic | Cardiovascular | Class 2 | 870.1650 | 2012-12-04 |
| KGZ | Accessories, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2020-03-24 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2019-04-30 |
| DXT | Injector And Syringe, Angiographic | Cardiovascular | Class 2 | 870.1650 | 2012-12-04 |
| DXT | Injector And Syringe, Angiographic | Cardiovascular | Class 2 | 870.1650 | 2012-12-04 |
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | Class 1 | 878.4020 | 2019-11-06 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2020-03-24 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2020-03-20 |
| OJH | Orthopedic Tray | General, Plastic Surgery | Class 1 | 878.4800 | 2015-07-09 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2012-11-21 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2019-11-06 |
| MMO | Tray, Surgical, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2012-11-21 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2020-03-20 |
| KDD | Kit, Surgical Instrument, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2012-11-06 |
| GBX | Catheter, Irrigation | General, Plastic Surgery | Class 1 | 878.4200 | 2012-11-29 |
| OYI | Non-Bronchoscopic Bronchoalveolar Lavage Catheter | Anesthesiology | Class 1 | 868.6810 | 2016-01-14 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4290 | 2012-12-04 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2020-03-03 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2020-03-03 |
| PEV | Dialysis Administration Kit | Gastroenterology, Urology | Class 2 | 876.5820 | 2021-10-15 |
| OCT | Anti Fog Solution And Accessories, Endoscopy | Gastroenterology, Urology | Class 2 | 876.1500 | 2019-11-06 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2020-03-24 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | Cardiovascular | Class 2 | 870.1310 | 2020-03-03 |
| FNN | Nipple, Lambs Feeding | General Hospital | Class 1 | 880.5640 | 2019-12-26 |
| KQM | Camera, Surgical And Accessories | General, Plastic Surgery | Class 1 | 878.4160 | 2019-11-06 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2016-09-26 |
| OJA | Intravenous Extension Tubing Set | General Hospital | Class 2 | 880.5440 | 2021-10-15 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2012-12-04 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2020-03-03 |
| FPK | Tubing, Fluid Delivery | General Hospital | Class 2 | 880.5440 | 2012-12-04 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2012-12-04 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2019-11-06 |
| OJG | Neurological Tray | Neurology | Class 1 | 882.4525 | 2015-07-09 |
| OEX | Cardiovascular Catheter Sheath Introducer Kit | Cardiovascular | Class 2 | 870.1340 | 2021-10-15 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2020-02-27 |
| OEQ | Angiography/Angioplasty Kit | Cardiovascular | Class 2 | 870.1650 | 2019-05-01 |
| KKX | Drape, Surgical, Antimicrobial | General, Plastic Surgery | Class 2 | 878.4370 | 2020-02-27 |
| HFS | Shield, Nipple | General Hospital | Class 1 | 880.5630 | 2019-12-26 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2012-11-26 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2020-03-20 |
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | Class 1 | 878.4018 | 2019-04-30 |
| HGY | Pump, Breast, Non-Powered | Obstetrics/Gynecology | Class 1 | 884.5150 | 2019-12-26 |
| GAJ | Stripper, Vein, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2019-11-13 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2020-02-27 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | Cardiovascular | Class 2 | 870.4360 | 2020-03-20 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4210 | 2020-03-20 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2020-03-20 |
| DWO | Needle, Biopsy, Cardiovascular | General, Plastic Surgery | Class 1 | 878.4800 | 2012-11-21 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4290 | 2020-03-24 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2020-03-03 |
| CCW | Laryngoscope, Rigid | Anesthesiology | Class 1 | 868.5540 | 2019-11-13 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2020-03-03 |
| KYZ | Syringe, Irrigating (Non Dental) | General Hospital | Class 1 | 880.6960 | 2019-11-13 |
| MMK | Container, Sharps | General Hospital | Class 2 | 880.5570 | 2019-11-06 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2019-11-06 |
| JCT | Prosthesis, Tracheal, Expandable | General, Plastic Surgery | Class 2 | 878.3720 | 2020-03-03 |
| KBZ | Snare, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-11-06 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2012-11-26 |
| OEZ | Cardiovascular Procedure Kit | Cardiovascular | Class 2 | 870.1200 | 2019-05-01 |
| DXT | Injector And Syringe, Angiographic | Cardiovascular | Class 2 | 870.1650 | 2012-12-04 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | General, Plastic Surgery | Class 1 | 878.4680 | 2019-11-06 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2012-11-26 |
| DRA | Catheter, Steerable | Cardiovascular | Class 2 | 870.1280 | 2020-03-24 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2020-03-24 |
| OJT | Aspiration Tray | General, Plastic Surgery | Class 1 | 878.4800 | 2015-07-09 |
| FRN | Pump, Infusion | General Hospital | Class 2 | 880.5725 | 2019-11-13 |
| KKX | Drape, Surgical, Antimicrobial | General, Plastic Surgery | Class 2 | 878.4370 | 2020-02-27 |
| DXT | Injector And Syringe, Angiographic | Cardiovascular | Class 2 | 870.1650 | 2012-12-04 |
| DXT | Injector And Syringe, Angiographic | Cardiovascular | Class 2 | 870.1650 | 2012-12-04 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2019-11-06 |
| JCT | Prosthesis, Tracheal, Expandable | General, Plastic Surgery | Class 2 | 878.3720 | 2020-03-03 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2020-03-10 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2020-03-03 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K892118 | Paramount Products, Inc. | NON-STERILE MASKS AND CAPS | 1989-04-20 |
| K101883 | St Jude Medical | 6F ENGAGE/ENGAGE TR INTRODUCER | 2010-09-07 |
| K034025 | Nmt Medical, Inc. | NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC | 2004-03-26 |
| K122854 | Arrow International (Subsidiary of Teleflex Inc.) | ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER | 2013-01-04 |
| K233691 | Acutus Medical, Inc. | FlexCath Cross Transseptal Solution | 2023-12-17 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0783-2020 | Abbott Medical | 2 | Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303 |
| Z-0789-2020 | Abbott Medical | 2 | Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential. |
| Z-0008-2008 | Lemaitre Vascular, Inc. | 2 | CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC) |
| Z-0039-05 | Medrad Inc | 2 | Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT |
| Z-0036-2010 | Alphatec Spine, Inc. | 1 | ROC Lumbar bolt caddy, Part Number: 81997-01-05.
Sterilization container for ROC bolts/screws. Product is used to contain spinal implants. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3006950086 | Merit Medical Nederland BV | Maastricht Airport Limburg, NL |
| 3009582362 | OXFORD PERFORMANCE MATERIALS, INC. | South Windsor, CT, US |
| 3012536737 | Merit Medical Canada Ltd. | Markham Ontario, CA |
| 1721676 | Sterigenics U.S., LLC | Salt Lake City, UT, US |
| 1724474 | Terumo BCT STERILIZATION SERVICES, Inc. | LAKEWOOD, CO, US |
1123137 when referencing this establishment in official correspondence.