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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
87865–87888 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 1998
UNIGRAFE
K982699 · LYC
Unicare Biomedical
Dental · 78d
Cleared Oct 20, 1998
VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM
K982888 · LJT
Boston Scientific Corp
General Hospital · 64d
Cleared Oct 20, 1998
ROEKO SEAL
K983037 · KIF
Roeko Ulm, Roescheisen GmbH & Co.
Dental · 50d
Cleared Oct 19, 1998
LEISEGANG VIDEO COLPOSCOPE
K981958 · HEX
Netoptix Corp.
Obstetrics & Gynecology · 137d
Cleared Oct 19, 1998
SPYGLASS 5 FR ANGIOGRAPHIC CATHETER
K982299 · DQO
Daig Corp.
Cardiovascular · 110d
Cleared Oct 19, 1998
BMP CABLE SYSTEM
K982545 · JDQ
Biomet, Inc.
Orthopedic · 90d
Cleared Oct 19, 1998
MLT 30 LASER
K982548 · GEX
Medical Laser Technologies , Ltd.
General & Plastic Surgery · 90d
Cleared Oct 19, 1998
SECURALLOY
K982671 · EJJ
Specialites Septodont
Dental · 80d
Cleared Oct 19, 1998
GC RELINE
K982695 · EBI
GC America, Inc.
Dental · 77d
Cleared Oct 19, 1998
ZINFOS ZINC PHOSPHATE CEMENT
K982913 · EMA
Scientific Pharmaceuticals, Inc.
Dental · 61d
Cleared Oct 19, 1998
DISETRONIC PEN
K982966 · FMF
Disetronic Medical Systems
General Hospital · 55d
Cleared Oct 19, 1998
PERITRON PERINEOMETER MODEL 9300V OR 9300A
K983052 · HIR
Cardio Design Pty. , Ltd.
Gastroenterology & Urology · 48d
Cleared Oct 19, 1998
VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS
K983381 · HEB
Paragon Trade Brands, Inc.
Obstetrics & Gynecology · 24d
Cleared Oct 19, 1998
SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER,...
K983406 · FLL
Banta Healthcare Group, Ltd.
General Hospital · 21d
Cleared Oct 16, 1998
UROSURGE UROTHERM FLUID WARMING SYSTEM
K965136 · LHC
Princeton Regulatory Assoc.
General Hospital · 662d
Cleared Oct 16, 1998
ENVY GUIDING CATHETER
K974774 · DQO
Cook, Inc.
Cardiovascular · 298d
Cleared Oct 16, 1998
PENETREASE
K980078 · FMF
P.T. Panca Pusaka Deli
General Hospital · 281d
Cleared Oct 16, 1998
TINAQUANT B 2-MICROGLOBULIN ASSAY
K980724 · JZG
Boehringer Mannheim Corp.
Immunology · 234d
Cleared Oct 16, 1998
AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY
K980907 · LPS
Axis Biochemicals, Asa
Chemistry · 220d
Cleared Oct 16, 1998
Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters
K981660 · DSP
C.R. Bard, Inc.
Cardiovascular · 158d
Cleared Oct 16, 1998
SERAQUEST RUBELLA IGM
K982281 · LFX
Quest Intl., Inc.
Microbiology · 108d
Cleared Oct 16, 1998
ARTHROTEK INTERFERENCE SCREW
K982497 · HWC
Biomet, Inc.
Orthopedic · 88d
Cleared Oct 16, 1998
COSMO PLUS WITH NICO, MODEL 8200
K982499 · BZC
Novametrix Medical Systems, Inc.
Anesthesiology · 88d
Cleared Oct 16, 1998
FLEXIMA
K982508 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 88d