FDA Device Registration & Listing · HOWELL, MI, US · Registration 1824619
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2022-05-19 |
| OHG | Circumcision Tray | Obstetrics/Gynecology | Class 2 | 884.4530 | 2011-04-12 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2017-09-27 |
| OIB | Blood And Urine Collection Kit (Excludes Hiv Testing) | Pathology | Class 1 | 864.3250 | 2011-04-12 |
| KDD | Kit, Surgical Instrument, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2003-04-25 |
| BYY | Tube, Aspirating, Flexible, Connecting | General Hospital | Class 2 | 880.6740 | 2008-08-14 |
| FMH | Container, Specimen, Sterile | Pathology | Class 1 | 864.3250 | 2001-08-21 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2011-01-13 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2011-01-13 |
| OFF | Central Venous Catheter Tray | Cardiovascular | Class 2 | 870.1140 | 2017-12-29 |
| KXG | Applicator, Absorbent Tipped, Sterile | General Hospital | Class 1 | 880.6025 | 2006-12-27 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2011-01-13 |
| FHB | Hook, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 2016-01-13 |
| OFX | General Purpose Dental Tray | Dental | Class 1 | 872.6640 | 2012-02-09 |
| MLS | Labor And Delivery Kit | Obstetrics/Gynecology | Class 2 | 884.4530 | 2008-06-25 |
| JZF | Tube, Ear Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-03-01 |
| ILD | Adaptor, Dressing | Physical Medicine | Class 1 | 890.5050 | 2012-05-17 |
| CCX | Support, Patient Position | Anesthesiology | Class 1 | 868.6820 | 2020-03-05 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2001-08-21 |
| PYA | Liver Biopsy Kit | General, Plastic Surgery | Class 1 | 878.4800 | 2018-06-08 |
| OFG | Ct Biopsy Tray | Cardiovascular | Class 2 | 870.4075 | 2018-03-01 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2017-09-27 |
| LYV | Label Or Tag, Sterile | General, Plastic Surgery | Class 1 | 878.4800 | 2006-12-27 |
| JOK | Scissors, Medical, Disposable | General Hospital | Class 1 | 880.6820 | 2008-06-19 |
| OES | Cardiac Catheterization Kit | Cardiovascular | Class 2 | 870.1200 | 2011-09-08 |
| OXQ | Dressing Change Tray | General Hospital | Class 1 | 880.5075 | 2012-03-08 |
| LWK | Razor, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2003-12-11 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2007-12-12 |
| PXO | Bone Marrow Biopsy Tray | General, Plastic Surgery | Class 1 | 878.4800 | 2017-09-06 |
| KYZ | Syringe, Irrigating (Non Dental) | General Hospital | Class 1 | 880.6960 | 2004-04-06 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | General, Plastic Surgery | Class 1 | 878.4450 | 2001-08-21 |
| EYJ | Holder, Ureteral Catheter | Gastroenterology, Urology | Class 1 | 876.5130 | 2009-08-27 |
| HFX | Clamp, Circumcision | Obstetrics/Gynecology | Class 2 | 884.4530 | 2008-01-16 |
| GFF | Bur, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4820 | 2013-12-18 |
| PWY | Lumbar Puncture Tray (Adult & Pediatric) | General Hospital | Class 2 | 880.5570 | 2017-09-07 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2008-11-06 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2008-06-19 |
| BSY | Catheters, Suction, Tracheobronchial | Anesthesiology | Class 1 | 868.6810 | 2001-08-21 |
| LRQ | Tracheostomy And Nasal Suctioning Kit | Unknown | Class 1 | N/A | 2011-04-12 |
| MCZ | Suture Removal Kit | General, Plastic Surgery | Class 1 | 878.4800 | 2008-01-25 |
| KMK | Device, Intravascular Catheter Securement | General Hospital | Class 1 | 880.5210 | 2006-03-17 |
| PUI | Drape, Surgical, Exempt | General, Plastic Surgery | Class 2 | 878.4370 | 2018-01-26 |
| OGR | Ear, Nose, And Throat Surgical Tray | Ear, Nose, Throat | Class 1 | 874.4420 | 2010-01-14 |
| LRO | General Surgery Tray | General, Plastic Surgery | Class 2 | 878.4370 | 2023-05-01 |
| LRS | I.V. Start Kit | General Hospital | Class 2 | 880.5200 | 2008-01-25 |
| KAI | Mirror, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-01-30 |
| FKG | Tray, Start/Stop (Including Contents), Dialysis | Gastroenterology, Urology | Class 1 | 876.5820 | 2009-06-12 |
| GAX | Tourniquet, Nonpneumatic | General, Plastic Surgery | Class 1 | 878.5900 | 2006-12-27 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3007128716 | Medline Industries, LP | Norristown, PA, US |
| 3036706541 | EXCELSIOR MEDICAL LLC | Tinton Falls, NJ, US |
| 3016073670 | Medline Logistics Japan G.K. | Nishihocho, Aisai-shi Aichi, JP |
| 3006581049 | MICROTEK MEDICAL MALTA LIMITED | Mosta, MT |
| 3010389834 | Microtek Medical B.V. Varsseveld | VARSSEVELD Gelderland, NL |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K150445 | Asahi Intecc Co., Ltd. | ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) | 2015-06-30 |
| K082922 | Lake Region Mfg., Inc. | FREEWAY AND RAILRUNNER GUIDEWIRES | 2008-12-09 |
| K890207 | E-Z-Em, Inc. | INTERVENTIONAL PRODUCTS - GUIDE WIRES | 1989-05-31 |
| K992169 | Advanced Cardiovascular Systems, Inc. | ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE | 1999-10-28 |
| K012534 | Advanced Cardiovascular Systems, Inc. | HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING | 2002-01-24 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0030-2009 | Boston Scientific Corporation | 2 | Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches. |
| Z-0031-2009 | Boston Scientific Corporation | 2 | Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches. |
| Z-0002-2024 | ARROW INTERNATIONAL Inc. | 2 | Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days |
| Z-0003-2024 | ARROW INTERNATIONAL Inc. | 2 | Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days |
| Z-0009-2023 | B Braun Medical Inc | 2 | Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3024743081 | EMBRACE MEDICAL LTD. | Tel Aviv, IL |
| 3042175841 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Best Noord-Brabant, NL |
| 3018070217 | SHANGHAI ACHIEVA MEDICAL SUZHOU CO., LTD. | Suzhou Jiangsu, CN |
| 3015522130 | NANO4IMAGING USA, LLC. | Dublin, OH, US |
| 3007635982 | Confluent Medical Technologies, Inc | Fremont, CA, US |
1824619 when referencing this establishment in official correspondence.