Panels › Gastroenterology, Urology › Product code GBM · Class 2
Catheter, Urethral
Regulation 876.5130
0510(k)s in 12 months (71 all time)
2recalls in 12 months (18 all time)
15recalls that name a 510(k)
Top companies in GBM
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 23, 1999 | K993651 | O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER Sc Hennig Enterprises Europe Srl, AU | GBM |
| Sep 3, 1999 | K992137 | UROLOGICAL CATHETER Apogee, Inc. | GBM |
| Feb 25, 1998 | K973120 | READYCATH CATHETER Medical Technologies of Georgia | GBM |
| Mar 13, 1997 | K970704 | PERSONAL CATHETER Rochester Medical Corp. | GBM |
| Jan 28, 1997 | K965067 | DILATION CATHETER, BALLOON Boston Scientific Corp | GBM |
| Oct 31, 1996 | K961361 | ASTA-CATH A+ Products | GBM |
| Aug 18, 1995 | K952924 | ADI CATHETER WITH VALVE Asia Dynamics, Inc. | GBM |
| Jan 31, 1995 | K943851 | ALL SILICONE INTERMITTENT CATHETER Rochester Medical Corp. | GBM |
| May 16, 1994 | K941672 | URI-CATH CATHETER Gesco Intl., Inc. | GBM |
| May 21, 1993 | K926369 | WALTHER CATHETERS, MALE, FEMALE Thomasville Medical Assoc. | GBM |
| Mar 20, 1992 | K914905 | ENTRAC(TM) URETHRAL MEASURING CATHETER American Medical Systems, Inc. | GBM |
| May 28, 1991 | K910876 | AUTOCATH(TM) SET Cook Urological, Inc. | GBM |
| Jun 22, 1990 | K901441 | ALBERT MORTON UROLOGICAL CATHETER Transinternational Marketing Group | GBM |
| Jun 20, 1990 | K901336 | ASI HEMOSTASIS CATHETER Advanced Surgical Intervention, Inc. | GBM |
| Jun 23, 1989 | K892442 | KENDALL CURITY URETHRAL CATHETERS The Kendal Co. | GBM |
| Aug 12, 1988 | K881667 | KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH The Kendal Co. | GBM |
| Aug 25, 1987 | K871999 | MMG URO-SELF CATHETER Medical Marketing Group | GBM |
| Apr 6, 1983 | K830840 | OPEN ENDED URETERAL CATHETER Van-Tec, Inc. | GBM |
| Aug 23, 1976 | K760254 | TRAY, FOLEY CATHETER C.R. Bard, Inc. | GBM |
| Aug 23, 1976 | K760253 | TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG C.R. Bard, Inc. | GBM |
| Aug 23, 1976 | K760093 | CATHETER, SILICONE FOLEY (BARDEX) C.R. Bard, Inc. | GBM |
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