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
164449–164472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1981
AUTOCLIX
K810075 · FMK
Biodynamics Corp.
General & Plastic Surgery · 22d
Cleared Feb 04, 1981
CELLONA PLASTER VARNISH
K810111 · ITG
Secol Co.
Physical Medicine · 19d
Cleared Feb 04, 1981
SWR DISPOSABLE PREP RAZOR
K810112 · KDC
G.D. Searle and Co.
General & Plastic Surgery · 19d
Cleared Feb 04, 1981
ISOROBIC SKINFOLD CALIPER
K810116 · KTZ
Fitness Motivation Institute of America
Orthopedic · 20d
Cleared Feb 04, 1981
REINFORCED HIP CUP
K810120 · JDI
Biomet, Inc.
Orthopedic · 19d
Cleared Feb 04, 1981
SWAN-GANZ VIP THERMODILUTION CATHETER
K810124 · DYG
American Edwards Laboratories
Cardiovascular · 16d
Cleared Feb 04, 1981
FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06
K810162 · DXC
American Edwards Laboratories
Cardiovascular · 13d
Cleared Feb 04, 1981
LAPAROTOMY SPONGE
K810184 · GDY
Medical Action Industries, Inc.
General & Plastic Surgery · 13d
Cleared Feb 04, 1981
MICROMEDIC SYSTEMS' AUTOPAK
K810186 · CGN
Micromedic Systems
Chemistry · 13d
Cleared Feb 04, 1981
TOXICOLOGY CONTROL
K810201 · LAS
Utak Laboratories, Inc.
Toxicology · 12d
Cleared Feb 04, 1981
POWERED PATIENT SYSTEM
K810220 · IKZ
Tri W-G, Inc.
Physical Medicine · 8d
Cleared Feb 04, 1981
LIMB ORHTOSIS
K810222 · ITQ
Medical Design & Manufacturing Corp.
Physical Medicine · 8d
Cleared Feb 02, 1981
ISO-BAC INSTRUMENT WRAP
K802919 · FRG
American Convertors Div., American...
General Hospital · 76d
Cleared Feb 02, 1981
TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300
K802978 · KLK
Brattle Instrument Corp.
Anesthesiology · 73d
Cleared Feb 02, 1981
ALGINATE/SILICONE CROWN & BRIDGE MATER
K802990 · ELW
Buffalo Dental Mfg. Co., Inc.
Dental · 70d
Cleared Feb 02, 1981
IONESCU-SHILEY AORTIC GRAFT VALVE
K803000 · DSY
Shiley, Inc.
Cardiovascular · 69d
Cleared Feb 02, 1981
AUTO-MATE CAMERA
K803157 · IYO
Aptek , Ltd.
Radiology · 60d
Cleared Feb 02, 1981
COMPRESSED AIR & OXYGEN GEN./DELIVERY SY
K803232 · CAW
Dri-Aire, Inc.
Anesthesiology · 42d
Cleared Feb 02, 1981
ASSAY STRIPS
K803244 · JTC
Corning Costar Corp.
Microbiology · 41d
Cleared Feb 02, 1981
SENSOMAT MUSCLE/TISSUE PH
K803260 · CBZ
Biochem International, Inc.
Anesthesiology · 40d
Cleared Feb 02, 1981
GUARDIAN STERILIZATION WRAP
K803294 · FRG
Kimberly-Clark Corp.
General Hospital · 34d
Cleared Feb 02, 1981
TOMOMATIC 64
K810006 · IZD
Medimatic
Radiology · 28d
Cleared Feb 02, 1981
SELECTRON REMOTE ISOTOPE
K810051 · JAQ
Victoreen, Inc.
Radiology · 34d
Cleared Feb 02, 1981
STANBIO BILIRUBIN TEST SET
K810055 · CIG
Stanbio Laboratory
Chemistry · 20d