Panels › Obstetrics/Gynecology › Product code HDF · Class 1
Speculum, Vaginal, Metal
Regulation 884.4520
0510(k)s in 12 months (11 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in HDF
| Company | 510(k)s | Recalls |
|---|---|---|
| Conphar, Inc. | 2 | 0 |
| Downs Surgical , Ltd. | 2 | 0 |
| Zinnanti Surgical Instruments, Inc. | 2 | 0 |
| Artiberia | 1 | 0 |
| Carefusion 2200 Inc | 0 | 1 |
| Centurion Medical Products Corporation | 0 | 1 |
| Franklin Medical USA, Inc. | 1 | 0 |
| Gynescope Corp. | 1 | 0 |
| Kinetic Medical Products | 1 | 0 |
| Sklar Instruments | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 28, 1994 | K926429 | VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT Thomasville Medical Assoc. | HDF |
| Jun 7, 1990 | K902019 | MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS Gynescope Corp. | HDF |
| Mar 22, 1989 | K891041 | MIYA SPECULUM Zinnanti Surgical Instruments, Inc. | HDF |
| Mar 17, 1989 | K891044 | LASER SPECULA Zinnanti Surgical Instruments, Inc. | HDF |
| Feb 13, 1989 | K890375 | VAGINAL SPECULUM Kinetic Medical Products | HDF |
| Nov 24, 1986 | K862478 | HAYES VAGINAL SHIELD Franklin Medical USA, Inc. | HDF |
| Oct 29, 1985 | K853640 | WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL Downs Surgical , Ltd., GB | HDF |
| May 22, 1985 | K851799 | 61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA Artiberia | HDF |
| Oct 1, 1984 | K843388 | WELLINGTON HOSPITAL PATTERN SELF-RETAIN Downs Surgical , Ltd. | HDF |
| May 24, 1982 | K821297 | GRAVES SPECULA Conphar, Inc. | HDF |
| May 24, 1982 | K821291 | PEDERSON VAGINAL SPECULA Conphar, Inc. | HDF |
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