HDA
10 FDA 510(k) clearances · Product code
90 daysmedian time to decision
697 days90th percentile
10clearances measured
FDA profile
- Official device name
- Forceps, Obstetrical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4400
- Medical specialty
- Obstetrics/Gynecology
- Adverse events (MAUDE)
- 2018: 30 · 2019: 20 · 2020: 15 · 2021: 21 · 2022: 13 · 2023: 30
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 |
|---|---|---|
| INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX (K100517) | Instrumed International, Inc. | 2010-04-29 |
| DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX (K092827) | Dimeda Instrumente GmbH | 2010-01-08 |
| TEKNO-MEDICAL OBSTETRICAL FORCEPS (K013747) | Tekno Medical Optik-Chirurgie GmbH & Co. | 2002-02-11 |
| V. MUELLER OBSTETRICAL (OB) FORCEPS (K951529) | Baxter Healthcare Corp | 1995-08-04 |
| CMI VACUUM PUMP (K914552) | Columbia Medical & Surgical, Inc. | 1993-09-07 |
| ILC FORCEPS PADS (K905583) | Inman Liebelt Corp. | 1991-04-12 |
| AUTO SUTURE(R) ENDOSCOPIC CLAMP (K903205) | United States Surgical, A Division of Tyco Healthc | 1990-10-11 |
| MIDWIFERY/OBSTETRICAL FORCEPS (K890385) | Kinetic Medical Products | 1989-03-01 |
| SIMPSON OBSTETRICAL FORCEPS-SS TYPE 410 OR 420 (K851883) | The Huxley Instrument Corp. | 1985-05-09 |
| FORCEPS, OB, NON-COMPRESSIVE (K771106) | Zeppelin Medizinlechnik GmbH | 1977-07-01 |
Track HDA automatically
Every clearance here is in the API, with alerts when new ones post.