Panels › Obstetrics/Gynecology › Product code KOH · Class 1
Instrument, Manual, General Obstetric-Gynecologic
Regulation 884.4520
0510(k)s in 12 months (15 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in KOH
| Company | 510(k)s | Recalls |
|---|---|---|
| Zinnanti Surgical Instruments, Inc. | 3 | 0 |
| Medikmark, Inc. | 2 | 0 |
| American V. Mueller | 1 | 0 |
| Boston Scientific Corporation | 0 | 1 |
| C. Intl. | 1 | 0 |
| C.R. Bard, Inc. | 1 | 0 |
| Imm Enterprises , Ltd. | 1 | 0 |
| KARL STORZ Endoscopy-America, Inc. | 1 | 0 |
| M. Joel Gebhart, D.D.S. | 1 | 0 |
| Ob/Gyn Concepts, Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 21, 2000 | K000212 | KSEA CHARDONNES MORCELLATION KNIFE KARL STORZ Endoscopy-America, Inc. | KOH |
| Jun 15, 1994 | K921732 | MINOR LAP SET Medikmark, Inc. | KOH |
| Jun 15, 1994 | K921730 | C-SECTION PACK Medikmark, Inc. | KOH |
| May 11, 1989 | K892693 | VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT Zinnanti Surgical Instruments, Inc. | KOH |
| May 11, 1989 | K891351 | NEWPORT LATERAL VAGINAL RETRACTOR Simpson/Basye, Inc. | KOH |
| Mar 22, 1989 | K891035 | NEEDLE EXTENSIONS Zinnanti Surgical Instruments, Inc. | KOH |
| Mar 17, 1989 | K891049 | ZEPPELIN SCISSORS Zinnanti Surgical Instruments, Inc. | KOH |
| Jan 7, 1987 | K863610 | THE OB-GYN CONCEPTS VAGINAL ASPIRATOR Ob/Gyn Concepts, Ltd. | KOH |
| Mar 5, 1984 | K840308 | CAT. 4-OBSTETRICS GYNECOLOGY DEV'S Imm Enterprises , Ltd. | KOH |
| Jan 18, 1983 | K823792 | QUARTZ RETRACTOR/PROBE American V. Mueller | KOH |
| Oct 13, 1981 | K812204 | UTERINE MANIPULATORS Reznik Instruments | KOH |
| Jun 30, 1980 | K800834 | SER-TEX V.S.S.I., Inc. | KOH |
| Jul 30, 1979 | K790851 | VAGI-PRESS #401 C. Intl. | KOH |
| Dec 7, 1978 | K781767 | INSTRUMENT CURNETT MINI-CONER BIOPSY C.R. Bard, Inc. | KOH |
| Jun 28, 1978 | K780460 | DENTAL AIR BRUSH M. Joel Gebhart, D.D.S. | KOH |
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