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 20, 1991 | K905614 | JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS Baxter Healthcare Corp | GBX |
| Mar 6, 1991 | K905766 | DRAINAGE TUBE RESTRAINT/WOUND COVER M. Imonti and Associates Inc., | GBX |
| Feb 11, 1991 | K905422 | PVC ROUND WOUND DRAINS Axiom Medical, Inc. | GBX |
| Oct 11, 1990 | K904133 | DISPOSABLE FLUID COLLECTION BAG Axiom Medical, Inc. | GBX |
| Dec 27, 1989 | K895756 | MIKRO-AQUAPURATOR Mikro-Tek Laboratories | GBX |
| Dec 27, 1989 | K895755 | MIKRO-LAVAGE-1 Mikro-Tek Laboratories | GBX |
| Dec 27, 1989 | K895516 | CAVITY DRAINAGE CATHETERIZATION SET, CS-01600 Arrow Intl., Inc. | GBX |
| Oct 19, 1989 | K895757 | IRRI-EVACUATOR Mikro-Tek Laboratories | GBX |
| Sep 13, 1988 | K883474 | THORACIC CATHETERS Westmark, Sterile Packing Systems, Inc. (Sps) | GBX |
| Mar 27, 1987 | K870704 | CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET American Pharmaseal Div. Ahsc | GBX |
| Jun 27, 1985 | K844809 | CONTINUOUS VENTILATOR Hamilton Medical, Inc. | GBX |
| Jun 26, 1985 | K852143 | HALL IRRIGATION SYSTEM Hall Surgical, Division of Zimmer, Inc. | GBX |
| Jun 5, 1985 | K844876 | PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16, Pennine Medical , Ltd., GB | GBX |
| May 21, 1985 | K844061 | MICROTEK IRRIGATION SYSTEM Microtek Medical, Inc. | GBX |
| May 3, 1985 | K851475 | VYGON CANNULA FOR SURGICAL SUCTION YAN KAUER 574/5 Vygon Corp. | GBX |
| Mar 18, 1985 | K844922 | PERIMETER THORACIC CATHETER Perimeter Medical, Inc. | GBX |
| Nov 29, 1984 | K844094 | PRUITT IRRIGATION AND OCCLUSION CATHETER Bionomy, Inc. | GBX |
| Oct 24, 1984 | K843617 | SDC SILICONE SUMP DRAIN Science Development Corp. | GBX |
| Aug 2, 1984 | K841362 | TIDAL DISTENSION IRRIGATION SET Abbott Laboratories | GBX |
| Apr 25, 1984 | K840323 | SILICONE SUCTION & IRRIGATION DRAIN Superior Plastic Products Corp. | GBX |
| May 2, 1983 | K830859 | I/A KIT Surgeon Surgical Instrumentation, Inc. | GBX |
| Dec 28, 1982 | K823496 | ARTHROSCOPIC IRRIGATION SETS-2C4030/31 Travenol Laboratories, S.A. | GBX |
| Oct 13, 1982 | K822510 | SUCTION CATHETER W/STERILE WATER Medine Dynacor | GBX |
| Jun 22, 1978 | K780788 | IRRIGATION CATHETER Shiley, Inc. | GBX |
| Sep 15, 1977 | K771079 | CURITY IRRIGATION TRAY Kendall Research Center | GBX |
| May 6, 1977 | K770706 | CATHETER, IRRIGATION Mallinckrodt Critical Care | GBX |
| Mar 30, 1977 | K770442 | SUMP DRAIN, W/FILTER, ARGYLE EDLICH Sherwood Medical Industries | GBX |
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