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
84985–85008 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 05, 1999
MAHE INSTRUMENTS
K991426 · FDC
Mahe Intl., Inc.
Gastroenterology & Urology · 104d
Cleared Aug 05, 1999
MICRO-STRIP FOR PHENCYCLIDINE METABOLITES
K991505 · LCM
Microdiagnostics, Inc.
Toxicology · 98d
Cleared Aug 05, 1999
MICRO-STRIP FOR MARIJUANA METABOLITES
K991516 · LDJ
Microdiagnostics, Inc.
Toxicology · 97d
Cleared Aug 05, 1999
CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS
K991594 · MSB
Sangstat Medical Corp.
Gastroenterology & Urology · 90d
Cleared Aug 05, 1999
PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE.
K991845 · LZA
Omnigrace , Ltd.
General Hospital · 69d
Cleared Aug 05, 1999
PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE
K991846 · LZA
Omnigrace , Ltd.
General Hospital · 69d
Cleared Aug 05, 1999
HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A
K991871 · MKJ
Hewlett-Packard Co.
Cardiovascular · 65d
Cleared Aug 05, 1999
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLOR
K991981 · LZA
Alliance Rubber Products Sdn. Bhd.
General Hospital · 52d
Cleared Aug 05, 1999
AUTOHDL CHOLESTEROL REAGENT SET
K992002 · LBR
Pointe Scientific, Inc.,
Chemistry · 51d
Cleared Aug 05, 1999
DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE
K992017 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 51d
Cleared Aug 05, 1999
LAGLOVE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM...
K992019 · KGO
La Glove (M) Sdn. Bhd.
General Hospital · 50d
Cleared Aug 05, 1999
CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY
K992157 · DBF
Chiron Diagnostics Corp.
Immunology · 41d
Cleared Aug 05, 1999
FLEXISCOPE IQ 101
K992362 · FET
Schoelly Fiberoptic GmbH
Gastroenterology & Urology · 21d
Cleared Aug 04, 1999
ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K973707 · MKZ
Roche Molecular Systems, Inc.
Microbiology · 674d
Cleared Aug 04, 1999
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES
K991028 · FGE
Cordis Corp.
Gastroenterology & Urology · 128d
Cleared Aug 04, 1999
QUICKVUE ONE-STEP H. PYLORI II TEST
K991747 · LYR
Quidel Corp.
Microbiology · 75d
Cleared Aug 04, 1999
EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)
K991903 · GWE
Excel Tech. , Ltd.
Neurology · 61d
Cleared Aug 04, 1999
INTRASTENT
K991929 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 57d
Cleared Aug 04, 1999
FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW...
K992275 · KDI
Fresenius USA, Inc.
Gastroenterology & Urology · 28d
Cleared Aug 04, 1999
VINYL POWDERED EXAM GLOVE / CAT.# 15-020
K992289 · LYZ
Vitalcare Group, Inc.
General Hospital · 28d
Cleared Aug 03, 1999
INTER-OP METASUL ACETABULAR SYSTEM
K974728 · KWA
Sulzer Orthopedics, Inc.
Orthopedic · 593d
Cleared Aug 03, 1999
RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED...
K990619 · BTR
Rusch Intl.
Anesthesiology · 159d
Cleared Aug 03, 1999
CARESIDE AMMONIA
K991371 · JID
Careside, Inc.
Chemistry · 105d
Cleared Aug 03, 1999
SOLUSTAPLE
K991566 · JDR
New Deal, S.A.
Orthopedic · 90d