FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
75937–75960 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 22, 2002
THERMOMETER MODELS ST8631
K021048 · FLL
Z7 International
General Hospital · 21d
Cleared Apr 19, 2002
EMS ELECTROSTATIC FLITER AND HME COMBINATION
K013122 · CAH
Engineered Medical Systems
General Hospital · 212d
Cleared Apr 19, 2002
BACTEC MGIT 960 SIRE KITS
K014123 · MJA
Becton, Dickinson & CO
Microbiology · 123d
Cleared Apr 19, 2002
BLADEWORKS MICROKERATOME BLADE, MODEL 7061
K020079 · HNO
Blade Works, Inc.
Ophthalmic · 99d
Cleared Apr 19, 2002
50S TRINGA ULTRASOUND IMAGING SYSTEM
K020112 · IYO
Pie Medical
Radiology · 98d
Cleared Apr 19, 2002
XR PRIMER 2
K020303 · KLE
Kerr Dental Materials Center
Dental · 80d
Cleared Apr 19, 2002
MODIFICATION TO FETAL ASSIST
K020390 · LQK
Huntleigh Diagnostics , Ltd.
Obstetrics & Gynecology · 72d
Cleared Apr 19, 2002
QAB2A IGM ELISA KIT
K020694 · MVS
Cheshire Diagnostics , Ltd.
Immunology · 46d
Cleared Apr 19, 2002
QAB2A IGG ELISA KIT
K020695 · MSV
Cheshire Diagnostics , Ltd.
Immunology · 46d
Cleared Apr 19, 2002
ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVE
K020918 · KGO
Eci Medical Technologies, Inc.
General Hospital · 29d
Cleared Apr 19, 2002
ATRICURE BIPOLAR SYSTEM, MODELS ASU1, ASU2, ASU3, LHP1, LHP2, RHP1
K020919 · GEI
AtriCure, Inc.
General & Plastic Surgery · 29d
Cleared Apr 19, 2002
TEKNIQUE-HOVEROUND POWER WHEEL CHAIR
K021136 · ITI
Hoveround Corp.
Physical Medicine · 10d
Cleared Apr 19, 2002
MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
K021213 · MAL
Boston Scientific Corp
Cardiovascular · 2d
Cleared Apr 18, 2002
VERSALAB APM
K013281 · HGM
Nicolet Biomedical
Obstetrics & Gynecology · 198d
Cleared Apr 18, 2002
BACT/ALERT FN CULTURE BOTTLE
K020815 · MDB
bioMerieux, Inc.
Microbiology · 36d
Cleared Apr 18, 2002
BACT/ALERT PF CULTURE BOTTLE
K020923 · MDB
bioMerieux, Inc.
Microbiology · 28d
Cleared Apr 18, 2002
BACT/ALERT SA CULTURE BOTTLE
K020931 · MDB
bioMerieux, Inc.
Microbiology · 27d
Cleared Apr 17, 2002
KSEA FIBERSCOPE
K011793 · LYK
KARL STORZ Endoscopy-America, Inc.
Cardiovascular · 313d
Cleared Apr 17, 2002
COMPEX SPORT
K011880 · NGX
Compex S.A.
Physical Medicine · 306d
Cleared Apr 17, 2002
TAMPONADE UTERINE BALLOON CATHETER SET
K013597 · KNA
Cook Ob/Gyn
Obstetrics & Gynecology · 168d
Cleared Apr 17, 2002
OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I
K013882 · JXM
OraSure Technologies, Inc.
Toxicology · 145d
Cleared Apr 17, 2002
NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000
K014274 · HKI
Nidek, Inc.
Ophthalmic · 111d
Cleared Apr 17, 2002
EMULATE FAST SET AND EMULATE REGULAR SET
K020242 · ELW
Cavex Holland BV
Dental · 84d
Cleared Apr 17, 2002
4 ALL (DW286A)
K020253 · EJH
Ivoclar Vivadent, Inc.
Dental · 83d