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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
122977–123000 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 1991
DB 3000 A-SCAN SYSTEM
K904692 · IYO
Ocuserv Instruments, Inc.
Radiology · 90d
Cleared Jan 14, 1991
BC 1220 ANALOG - IMPLANT BODY
K904711 · DZE
Minimatic Implant Technology
Dental · 90d
Cleared Jan 14, 1991
CHLAMYDIA SYSTEM SOFTWARE (CSS)
K904725 · LJC
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 89d
Cleared Jan 14, 1991
ELIACHAR MODIFIED ESOPHAGEAL STENT
K904821 · ESW
Hood Laboratories
Gastroenterology & Urology · 82d
Cleared Jan 14, 1991
CT HILIGHT ADVANTAGE II
K904971 · JAK
GE Medical Systems
Radiology · 70d
Cleared Jan 14, 1991
THE BODY COOLER SYSTEM
K904998 · ILO
Costa / French
Physical Medicine · 69d
Cleared Jan 14, 1991
QUIDEL TOTAL IGE POSITIVE CONTROL SERUM
K905162 · DHB
Quidel Corp.
Immunology · 59d
Cleared Jan 14, 1991
PACSNET RESEARCH TOOLKIT
K905199 · LMD
Siemens Gammasonics, Inc.
Radiology · 55d
Cleared Jan 14, 1991
DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT.
K905231 · CBH
Dale Medical Products, Inc.
Anesthesiology · 55d
Cleared Jan 14, 1991
THE THERATEST ACA TEST
K905301 · GFO
Theratest Laboratories, Inc.
Immunology · 48d
Cleared Jan 14, 1991
ULTRA WAVE 101
K905836 · IRO
Ako USA, Inc.
Physical Medicine · 14d
Cleared Jan 14, 1991
ACME MODEL 8500 WHEELCHAIR SCALE
K910055 · INF
Acme Medical Scale Co.
Physical Medicine · 7d
Cleared Jan 11, 1991
MODULAR UNIPOLAR SYSTEM
K902365 · KWL
Howmedica Corp.
Orthopedic · 226d
Cleared Jan 11, 1991
SRI JOHANI LATEX SURGEONS GLOVES
K904662 · KGO
Transcorp
General Hospital · 88d
Cleared Jan 11, 1991
MODEL IW17.5A INTRA OPERATIVE TRANSDUCER
K904665 · ITX
Kretztechnik AG
Radiology · 88d
Cleared Jan 11, 1991
CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR
K904806 · KDJ
Fresenius USA, Inc.
Gastroenterology & Urology · 79d
Cleared Jan 11, 1991
VASCULAR ACCESS PORT CONTINUOUS INFUSION SETS
K904886 · FPA
Florida Infusion Services, Inc.
General Hospital · 77d
Cleared Jan 11, 1991
TRACH COLLAR
K904974 · CBH
Rotek Corp.
Anesthesiology · 80d
Cleared Jan 11, 1991
ABUSCREEN ONLINE TM FOR THC
K904996 · LAT
Roche Diagnostic Systems, Inc.
Toxicology · 65d
Cleared Jan 11, 1991
MODEL 3100-21: QUADRATURE SPINE COIL
K905095 · LNH
Medical Advances, Inc.
Radiology · 59d
Cleared Jan 11, 1991
IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER
K905215 · JJQ
Cirrus Diagnostics, Inc.
Chemistry · 52d
Cleared Jan 11, 1991
MOOR LASER BLOOD FLOW MONITOR MBF3
K905232 · GEX
Moor Instruments, Ltd.
General & Plastic Surgery · 52d
Cleared Jan 11, 1991
MOOR LASER BLOOD FLOW MONITOR MBF3D
K905233 · GEX
Moor Instruments, Ltd.
General & Plastic Surgery · 52d
Cleared Jan 11, 1991
PERRY XTENDA CUFF SURGICAL GLOVES
K905537 · KGO
Smith & Nephew Perry
General Hospital · 31d