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
117481–117504 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 09, 1992
OSTEO EX-FI-RE
K920149 · JEC
Osteo AG
Orthopedic · 90d
Cleared Apr 08, 1992
IMMUNODOT BORRELIA (LYME) TEST
K911627 · LSR
General Biometrics, Inc.
Microbiology · 363d
Cleared Apr 08, 1992
CATHETER WITH INTRODUCER AND SYRINGES
K915129 · GCA
Utah Pioneer Medical, Inc.
Gastroenterology & Urology · 147d
Cleared Apr 08, 1992
SYNELISA TMAB
K915133 · JZO
Elias U.S.A., Inc.
Immunology · 147d
Cleared Apr 08, 1992
SYNELISA TGAB
K915134 · JZO
Elias U.S.A., Inc.
Immunology · 147d
Cleared Apr 08, 1992
SYNELISA TGAB/TMAB
K915135 · JZO
Elias U.S.A., Inc.
Immunology · 147d
Cleared Apr 08, 1992
CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
K915454 · LIO
Medical Packaging Corp.
Microbiology · 125d
Cleared Apr 08, 1992
IAS ANESTHESIA MASK
K915558 · BSJ
Ias
Anesthesiology · 119d
Cleared Apr 08, 1992
TITANIUM ALLOY SONGER CABLE SYSTEM
K920201 · JDQ
Sofamor Danek Mfg., Inc.
Orthopedic · 84d
Cleared Apr 08, 1992
SENSORMEDICS MODEL 922 SPIROMETER
K920246 · BZG
Sensor Medics Corp.
Anesthesiology · 78d
Cleared Apr 08, 1992
ACS TOTAL IGE IMMUNOASSAY
K920372 · DGC
Ciba Corning Diagnostics Corp.
Immunology · 71d
Cleared Apr 08, 1992
SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB
K920416 · LIB
Behring Diagnostics, Inc.
Microbiology · 68d
Cleared Apr 08, 1992
LORACARBEF 30MCG, SENSI DISC
K920786 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 48d
Cleared Apr 08, 1992
TEMAFLOXCIN, 5MCG, SENSI DISC
K920787 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 48d
Cleared Apr 08, 1992
ELISA TUBE LH TEST KIT
K920920 · CEP
Bio Clinic Co.
Chemistry · 40d
Cleared Apr 08, 1992
ELISA TUBE PROLACTIN TEST KIT
K920921 · CFT
Bio Clinic Co.
Chemistry · 40d
Cleared Apr 08, 1992
PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG
K921012 · LCX
Bd Becton Dickinson Vacutainer...
Chemistry · 36d
Cleared Apr 08, 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921176 · CEP
Vitek Systems, Inc.
Chemistry · 28d
Cleared Apr 07, 1992
C-SECTION TRAY
K912075 · KNA
Medical Device Inspection Co., Inc.
Obstetrics & Gynecology · 333d
Cleared Apr 07, 1992
THE BODYGUARDS PLUS HYPO ALLERGENIC LATEX EXAM GLO
K913642 · LYY
T.K. Glove Products
General Hospital · 244d
Cleared Apr 07, 1992
PRODIGY ND:YAG SURGICAL LASER SYSTEM
K914679 · GEX
Xintec Corporation
General & Plastic Surgery · 172d
Cleared Apr 07, 1992
CDG GAIT ANALYSES SYSTEM
K915278 · JFC
Wrm Computers
Physical Medicine · 134d
Cleared Apr 07, 1992
HEMAGEN ENA [JO-1] KIT (EIA METHOD)
K915420 · LLL
Hemagen Diagnostics, Inc.
Immunology · 127d
Cleared Apr 07, 1992
FPL
K915897 · IKE
Wrm Computers
Physical Medicine · 134d