Panels › Obstetrics/Gynecology › Product code HIB · Class 2
Speculum, Vaginal, Nonmetal
Regulation 884.4530
1510(k)s in 12 months (72 all time)
1recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in HIB
| Company | 510(k)s | Recalls |
|---|---|---|
| CooperSurgical, Inc. | 1 | 4 |
| Welch Allyn, Inc. | 3 | 1 |
| C.I.S.A. Import Export C/O Larson and Taylor | 3 | 0 |
| Sol Weiss MD, Inc. | 3 | 0 |
| Exitec, Inc. | 2 | 0 |
| Femspec LLC | 2 | 0 |
| Martin Medical | 2 | 0 |
| Zinnanti Surgical Instruments, Inc. | 2 | 0 |
| A & A Medical, Inc. | 1 | 0 |
| Adept-Med Intl., Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 30, 1994 | K930954 | THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV Cabot Medical Corp. | HIB |
| Apr 21, 1994 | K922154 | INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION Olsen Electrosurgical, Inc. | HIB |
| Mar 25, 1994 | K935636 | GRAVESPEC Adept-Med Intl., Inc. | HIB |
| Mar 7, 1994 | K933521 | SPECULUM Bioteque America, Inc. | HIB |
| Feb 25, 1994 | K926536 | DISPOSABLE PLASTIC VAGINAL SPECULA Thomasville Medical Assoc. | HIB |
| Oct 19, 1992 | K920803 | HSG TRAY Unimar, Inc. | HIB |
| Sep 19, 1990 | K903080 | DISPOSABLE PLASTIC VAGINAL SPECULUM Dawnex Industries, Inc. | HIB |
| Sep 12, 1990 | K903744 | PHYSICIAN'S CHOICE Advance Medical Device, Inc., CA | HIB |
| Oct 12, 1989 | K894957 | DISPOSABLE PLASTIC VAGINAL SPECULA Zinnanti Surgical Instruments, Inc. | HIB |
| Oct 5, 1989 | K894489 | GYNECOLOGIC EXAMINATION KIT A & A Medical, Inc. | HIB |
| Dec 20, 1988 | K880588 | AUTOEXPANDABLE SPECULUM MODEL LEIBOVIC LARGE #4 C.I.S.A. Import Export C/O Larson and Taylor | HIB |
| Dec 20, 1988 | K880587 | AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #3 C.I.S.A. Import Export C/O Larson and Taylor | HIB |
| Dec 20, 1988 | K880586 | AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH SMALL #2 C.I.S.A. Import Export C/O Larson and Taylor | HIB |
| Sep 15, 1988 | K882605 | EURO-MED CLEAR-VUE DISPOSABLE VAGINAL SPECULUM Buckman Co., Inc. | HIB |
| Sep 2, 1986 | K863275 | MARTIN MEDICAL PRO-SPEC SMALL VAGINAL SPECULUM Martin Medical | HIB |
| Sep 2, 1986 | K863274 | MARTIN MEDICAL PRO-SPEC MEDIUM VAGINAL SPECULUM Martin Medical | HIB |
| Aug 17, 1984 | K842014 | HOSPITAL'S-SPEC Merex Co. | HIB |
| Jul 31, 1984 | K841909 | VAGINAL SPECULUM - DISPOSABLE Galenica Enterprises, Inc. | HIB |
| Jul 13, 1984 | K841867 | KIDD VAGINAL SPECULUM Paul H. Schneider Ent. | HIB |
| Apr 27, 1983 | K830725 | GENT-L-SPEC DISPOS. VAGINAL SPECULUM Geneva Laboratories, Inc. | HIB |
| Nov 8, 1982 | K822086 | DIA-SPEC Exitec, Inc. | HIB |
| Aug 19, 1982 | K822084 | PRO-SPEC Exitec, Inc. | HIB |
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