Panels › General, Plastic Surgery › Product code GBX · Class 1
Catheter, Irrigation
Regulation 878.4200
0510(k)s in 12 months (77 all time)
7recalls in 12 months (83 all time)
3recalls that name a 510(k)
Top companies in GBX
| Company | 510(k)s | Recalls |
|---|---|---|
| Cardinal Health 200, LLC | 0 | 53 |
| Degania Silicone, Ltd. | 0 | 10 |
| Rocket Medical Plc | 0 | 6 |
| Navarre Biomedical , Ltd. | 5 | 0 |
| Sil-Med Corp. | 5 | 0 |
| Axiom Medical, Inc. | 3 | 0 |
| Hospira Inc. | 0 | 3 |
| Kendall Healthcare Products Co. Div.Of Tyco Health | 3 | 0 |
| Mikro-Tek Laboratories | 3 | 0 |
| Baxter Healthcare Corp | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 3, 2014 | K131659 | MOERAE VEIN PREPARATION KIT Moerae Matrix, Inc. | GBX |
| Dec 17, 2008 | K082725 | GRAFTGUARD PRESSURE CONTROLLING SYRINGE Maquet Cardiovascular, LLC | GBX |
| Oct 21, 2005 | K052286 | DEUTSCH ANTI-BLOCKAGE WOUND DRAIN The Catheter Exchange, Inc. | GBX |
| Mar 31, 2005 | K043515 | GRAFTSAVER Vescare, Inc. | GBX |
| Jan 10, 2002 | K013417 | MISONIX IRRIGATION SYSTEM MOEDL BC20P Misonix, Inc. | GBX |
| May 19, 2000 | K000704 | DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) Dmc Medical, Ltd. | GBX |
| Feb 3, 1998 | K974233 | LYSONIX IRRIGATION SYSTEM Lysonix, Inc. | GBX |
| Dec 4, 1997 | K973703 | JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN Allegiance Healthcare Corp. | GBX |
| Oct 1, 1997 | K972635 | ULTRACELL SUCTION SPONGE Ultracell Medical Technologies, Inc. | GBX |
| Mar 10, 1997 | K965146 | FLAT CLOSED WOUND DRAIN WITH TROCAR Axiom Medical, Inc. | GBX |
| Jun 26, 1996 | K961295 | SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR Sil-Med Corp. | GBX |
| May 31, 1996 | K961147 | CLOSED FLUID COLLECTION SYSTEM B.Braun Medical, Inc. | GBX |
| May 22, 1996 | K960955 | JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING Baxter Healthcare Corp | GBX |
| Mar 13, 1996 | K955339 | HYDROLOGY 5000 Northgate Technologies, Inc. | GBX |
| Feb 13, 1996 | K955474 | NEO-PNEUMOCATH Intra Special Catheters GmbH | GBX |
| Feb 7, 1996 | K955505 | OPTI-DRAIN MULTI-USE DRAINAGE CATHETER Navarre Biomedical , Ltd. | GBX |
| Dec 26, 1995 | K955439 | THE REEL THING (MODIFICATION) Biomedical Devices, Inc. | GBX |
| May 24, 1995 | K926496 | SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN Sil-Med Corp. | GBX |
| May 15, 1995 | K951907 | NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER Navarre Biomedical , Ltd. | GBX |
| Apr 24, 1995 | K951475 | NAVARRE UNIVERSAL DRAINAGE CATHETER Navarre Biomedical , Ltd. | GBX |
| Mar 14, 1995 | K950439 | INSYTE SIDEHOLDED DRAINAGE CATHETER Becton Dickinson Vascular Access, Inc. | GBX |
| Mar 14, 1995 | K950437 | ANGIOCATH SIDEHOLDER DRAINAGE CATHETER Becton Dickinson Vascular Access, Inc. | GBX |
| Aug 9, 1994 | K942335 | ACI SILICATH THORACIC CATHETER American Catheter | GBX |
| Jul 27, 1994 | K925243 | DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER Deknatel, Inc., CR | GBX |
| Jun 7, 1994 | K940156 | THE REEL THING Bio-Medical Devices, Inc. | GBX |
| Jun 2, 1994 | K942274 | ORION SUCTION CATHETER KIT WITH STERILE SALINE Regulatory & Marketing Services, Inc. | GBX |
| Jun 2, 1994 | K942273 | ORION SUCTION CATHETER KIT WITH STERILE WATER Regulatory & Marketing Services, Inc. | GBX |
| May 5, 1994 | K935531 | OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP Puritas Health Care, Inc. | GBX |
| Apr 14, 1994 | K940352 | STORZ N5941 SERIES MEDICAL GRADE TUBING Storz Instrument Co. | GBX |
| Mar 28, 1994 | K933600 | NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS Navarre Biomedical , Ltd. | GBX |
| Feb 2, 1994 | K926495 | SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPE Sil-Med Corp. | GBX |
| Feb 2, 1994 | K926408 | SIL-SLIP FLAT SUCTION DRAIN Sil-Med Corp. | GBX |
| Jan 27, 1994 | K932391 | NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET Navarre Biomedical , Ltd. | GBX |
| Jan 3, 1994 | K932205 | ERCP CATHETER, HYDROPHILIC COATED Wilson-Cook Medical, Inc. | GBX |
| Aug 11, 1993 | K925117 | URESIL ABSCESS DRIANAGE AND IRRIGATION SET Uresil Corp. | GBX |
| Jun 7, 1993 | K926109 | FLUID DRAINAGE TRAY Symbiosis Corp. | GBX |
| May 12, 1993 | K930551 | KENDALL UNIVERSAL EXTENSION SET Kendall Healthcare Products Co. Div.Of Tyco Health | GBX |
| Apr 23, 1993 | K923667 | IRRIGATION/SUCTION PROBE Surgical Instrument, Inc. | GBX |
| Apr 8, 1993 | K925176 | VANSONNENBERG CHEST DRAINAGE CATHETER ALL PURPOSE Boston Scientific Corp | GBX |
| Feb 26, 1993 | K925805 | KENDALL WOUND DRAINAGE SYSTEMS-TROCARS Kendall Healthcare Products Co. Div.Of Tyco Health | GBX |
| Jan 13, 1993 | K925748 | KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN Kendall Healthcare Products Co. Div.Of Tyco Health | GBX |
| Jan 12, 1993 | K925533 | ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET Angeion Corp. | GBX |
| Jan 12, 1993 | K924702 | TURKEL ABDOMINAL PARACENTESIS SYSTEM Symbiosis Corp. | GBX |
| Sep 28, 1992 | K921424 | SIL-MED FLAT SUCTION DRAIN Sil-Med Corp. | GBX |
| Aug 6, 1992 | K922739 | HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHMENT DEVICE Hollister, Inc. | GBX |
| Jul 15, 1992 | K921934 | INTRADUCER Taut, Inc. | GBX |
| Apr 29, 1992 | K921095 | PACER DISPOSABLE YANKAUER SUCTION INSTRUMENT Pacer Tool & Plastics, Inc. | GBX |
| Jan 21, 1992 | K913542 | THORACIC CATHETER WITH GUIDE Intl. Medical Devices , Ltd. | GBX |
| Jan 21, 1992 | K913539 | THORACIC CATHTER STYLET Intl. Medical Devices , Ltd. | GBX |
| Apr 22, 1991 | K910245 | I/A HANDPIECE WITH REPLACEABLE TIPS Surgical Technologies, Inc. | GBX |
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