FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
171673–171696 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 1978
LAS-R HUMAN IGD TEST
K772327 · CZJ
Hyland Therapeutic Div., Travenol...
Immunology · 69d
Cleared Feb 28, 1978
RIALYZE DIGOXIN
K780075 · DPG
Miles Laboratories, Inc.
Toxicology · 43d
Cleared Feb 28, 1978
BED BOARD
K780230 · FPS
Biomet, Inc.
General Hospital · 19d
Cleared Feb 28, 1978
HEMOPEXIN NEPHELOMETRIC ASSAYS
K780250 · CZX
Kallestad Laboratories, Inc.
Immunology · 14d
Cleared Feb 28, 1978
BONE CEMENT APPLICATOR
K780266 · KIH
Zimmer, Inc.
Orthopedic · 11d
Cleared Feb 28, 1978
INFLUENZA HA ANTIGEN
K780272 · GNT
Flow Laboratories, Inc.
Microbiology · 11d
Cleared Feb 28, 1978
INFLUENZA HI PRESERUM
K780273 · GNS
Flow Laboratories, Inc.
Microbiology · 11d
Cleared Feb 28, 1978
INFLUENZA HI ANTISERUM
K780274 · GNS
Flow Laboratories, Inc.
Microbiology · 11d
Cleared Feb 28, 1978
INFLUENZA HA ANTIGEN A/USSR
K780275 · GNT
Flow Laboratories, Inc.
Microbiology · 11d
Cleared Feb 28, 1978
INFLUENZA HI ANTISERUM A/TEXAS
K780276 · GNS
Flow Laboratories, Inc.
Microbiology · 11d
Cleared Feb 28, 1978
INFLUENZA HI PRESERUM A/TEXAS
K780277 · GNS
Flow Laboratories, Inc.
Microbiology · 11d
Cleared Feb 28, 1978
BARRIER HIP PACK W/ FABRIC 450
K780282
Surgikos, Inc.
Physical Medicine · 7d
Cleared Feb 28, 1978
BRACHIAL-LARGE VESSEL APPROXIMATOR
K780286 · GDJ
Edward Weck, Inc.
General & Plastic Surgery · 7d
Cleared Feb 28, 1978
BRACHEAL-LARGE VESSEL CLIP
K780288 · GDJ
Edward Weck, Inc.
General & Plastic Surgery · 7d
Cleared Feb 28, 1978
ULNAR-RADIAL CLIP
K780290 · GDJ
Edward Weck, Inc.
General & Plastic Surgery · 7d
Cleared Feb 28, 1978
ULNAR-RADIAL APPROXIMATER
K780291 · GDJ
Edward Weck, Inc.
General & Plastic Surgery · 7d
Cleared Feb 28, 1978
ELECTRO-SURGICAL GROUNDING PAD
K780298 · GEI
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 6d
Cleared Feb 28, 1978
HIP PLATE REMOVAL INSTRUMENT
K780300 · HWB
Richard'S Medical Equip., Inc.
Orthopedic · 6d
Cleared Feb 28, 1978
CAULK TYLOK
K780301 · EMA
L.D. Caulk Co.
Dental · 6d
Cleared Feb 28, 1978
IN-THE-EAR HEARING AID, MODEL CE-3
K780309 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 5d
Cleared Feb 27, 1978
PREDICTOR
K780240 · LCX
Organon, Inc.
Chemistry · 14d
Cleared Feb 27, 1978
IMPCO DISPOSABLE AORTIC PUNCH
K780247 · DWS
Thoratec Laboratories Corp.
Cardiovascular · 14d
Cleared Feb 27, 1978
COMPUTER AUDIOMETER - MA25
K780269 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 6d
Cleared Feb 27, 1978
COMPUTER AUDIOMETER - MA26
K780270 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 6d