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
173857–173880 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 1977
REAGENT SYSTEM
K770242 · CGX
American Monitor Corp.
Chemistry · 15d
Cleared Feb 18, 1977
API 3S
K770176 · JSE
Analytical Products, Inc.
Microbiology · 23d
Cleared Feb 18, 1977
HPC TM (HEPARINIZED PLASMA CONTROL)
K770188 · GGC
Bio/Data Corp.
Hematology · 21d
Cleared Feb 18, 1977
MONITOR, MYO, MODEL J3
K770252 · NUW
Myo-Tronics Research, Inc.
Dental · 9d
Cleared Feb 18, 1977
DIALYSATE METER RS-2100A, CIRCUIT CHANGE
K770263 · FLB
Renal Systems, Inc.
Gastroenterology & Urology · 7d
Cleared Feb 18, 1977
MARTIN-LEWIS AGAR MEDIUM
K770287 · JTY
Gibco Laboratories Life Technologies,...
Microbiology · 4d
Cleared Feb 18, 1977
SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125
K770291 · FAM
Welch Allyn, Inc.
Gastroenterology & Urology · 4d
Cleared Feb 17, 1977
STIMULATOR, ELECTRICAL MUSCLE (#MD-4)
K760547 · IPF
R. A. Fischer Co. Corp.
Physical Medicine · 171d
Cleared Feb 17, 1977
IRRIGATION CATHETER
K760556 · KDH
Sherwood Medical Industries
Gastroenterology & Urology · 169d
Cleared Feb 17, 1977
PROBE, VACUUM INSULATED, SERIES 30
K770058 · GEH
Spembly Medical , Ltd.
General & Plastic Surgery · 37d
Cleared Feb 17, 1977
MONITOR, OXYGEN, MODEL 78216C
K770207 · CCL
Hewlett-Packard Co.
Anesthesiology · 17d
Cleared Feb 17, 1977
WATSON-FARRAR TOTAL HIP REPLACEMENT
K770219 · JDG
Orthopedic Equipment Co., Inc.
Orthopedic · 14d
Cleared Feb 17, 1977
MEMLITE (PLASTIC EYEGLASS FRAMES)
K770221 · HQZ
American Optical Corp.
Ophthalmic · 14d
Cleared Feb 17, 1977
IRIS RETRACTOR
K770222 · HNI
Concept, Inc.
Ophthalmic · 14d
Cleared Feb 17, 1977
CATHETERS, SILICONE COATED
K770256 · KOD
Pharmaseal Div., Baxter Healthcare Corp.
Gastroenterology & Urology · 7d
Cleared Feb 16, 1977
NECKSAVER
K760644 · IQK
Health Saver Corp.
Physical Medicine · 154d
Cleared Feb 16, 1977
SKIN PRESSURE PROTECTORS
K761268 · FMP
Mark One Healthcare Products
General Hospital · 62d
Cleared Feb 16, 1977
BACTERIA SAMPLER
K770014
Bd Becton Dickinson Vacutainer...
Cardiovascular · 44d
Cleared Feb 16, 1977
PLATELET-CHEX-HUMAN
K770020 · JPK
Streck Laboratories, Inc.
Hematology · 41d
Cleared Feb 16, 1977
GAS CHROMOTOGRAPHS, SIGMA 1,2,3,4,&10
K770025 · KZQ
The Perkin-Elmer Corp.
Toxicology · 41d
Cleared Feb 16, 1977
COUNTER, BLOOD CELL & HEMATOCRIT
K770034 · GKL
Mallinckrodt Critical Care
Hematology · 37d
Cleared Feb 16, 1977
PACEGUARD
K770264 · DXH
Cardio Data
Cardiovascular · 5d
Cleared Feb 15, 1977
KARAYA GUM PRODUCTS - PROCESS CHANGE
K761319 · EZR
Howmedica Corp.
Gastroenterology & Urology · 50d
Cleared Feb 15, 1977
SUB. OF DIACETONE ACRYLAMIDE
K770180 · FPX
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 19d