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
75433–75456 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 17, 2002
UTERINE INJECTOR
K020292 · LKF
Catheter Research, Inc.
Obstetrics & Gynecology · 79d
Cleared Apr 17, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH...
K020319 · LON
Dade Behring, Inc.
Microbiology · 77d
Cleared Apr 17, 2002
MYALLERGYTEST SYSTEM
K020387 · DHB
Immunetech Corporation
Immunology · 71d
Cleared Apr 17, 2002
PULPDENT GLAZE
K020432 · EBF
Pulpdent Corporation
Dental · 68d
Cleared Apr 17, 2002
PULPDENT POST CEMENT
K020481 · EMA
Pulpdent Corporation
Dental · 63d
Cleared Apr 17, 2002
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE...
K020506 · LON
Dade Microscan, Inc.
Microbiology · 61d
Cleared Apr 17, 2002
BACT/ALERT FA CULTURE BOTTLE
K020813 · MDB
bioMerieux, Inc.
Microbiology · 35d
Cleared Apr 17, 2002
NXSTAGE THERAPY SYSTEM
K020858 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 30d
Cleared Apr 17, 2002
EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900
K020864 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 30d