HDF
11 FDA 510(k) clearances · Product code
27 daysmedian time to decision
147 days90th percentile
11clearances measured
FDA profile
- Official device name
- Speculum, Vaginal, Metal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.4520
- Medical specialty
- Obstetrics/Gynecology
- Adverse events (MAUDE)
- 1997: 1 · 1998: 1 · 2001: 2 · 2003: 1 · 2007: 4 · 2019: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT (K926429) | Thomasville Medical Assoc. | 1994-02-28 |
| MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS (K902019) | Gynescope Corp. | 1990-06-07 |
| MIYA SPECULUM (K891041) | Zinnanti Surgical Instruments, Inc. | 1989-03-22 |
| LASER SPECULA (K891044) | Zinnanti Surgical Instruments, Inc. | 1989-03-17 |
| VAGINAL SPECULUM (K890375) | Kinetic Medical Products | 1989-02-13 |
| HAYES VAGINAL SHIELD (K862478) | Franklin Medical USA, Inc. | 1986-11-24 |
| WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL (K853640) | Downs Surgical , Ltd. | 1985-10-29 |
| 61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA (K851799) | Artiberia | 1985-05-22 |
| WELLINGTON HOSPITAL PATTERN SELF-RETAIN (K843388) | Downs Surgical , Ltd. | 1984-10-01 |
| PEDERSON VAGINAL SPECULA (K821291) | Conphar, Inc. | 1982-05-24 |
| GRAVES SPECULA (K821297) | Conphar, Inc. | 1982-05-24 |
Track HDF automatically
Every clearance here is in the API, with alerts when new ones post.