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
72769–72792 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 2003
THE MULTILIFT
K024346 · ING
Services Industriels Savaria, Inc.
Physical Medicine · 67d
Cleared Mar 04, 2003
ANESTHESIA MONITOR
K030105 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 50d
Cleared Mar 04, 2003
IGLIDE MANUAL ASSIST WHEELCHAIR
K030250 · ITI
Independence Technology, LLC
Physical Medicine · 39d
Cleared Mar 04, 2003
CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00
K030265 · JDI
Zimmer, Inc.
Orthopedic · 36d
Cleared Mar 04, 2003
MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS
K030344 · KWS
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Mar 04, 2003
CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT,...
K030408 · GKZ
Beckman Coulter, Inc.
Hematology · 25d
Cleared Mar 04, 2003
SKINTACT ECG TAB ELECTRODE
K030509 · DRX
Leonhard Lang GmbH
Cardiovascular · 13d
Cleared Mar 03, 2003
MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005
K021537 · GXY
Vermont Medical, Inc.
Neurology · 297d
Cleared Mar 03, 2003
BABYCARE
K023082 · HEP
Bionet Company, Ltd.
Radiology · 167d
Cleared Mar 03, 2003
MIDMARK M9 ULTRACLAVE STEAM STERILIZER
K023348 · FLE
Midmark Corp.
General Hospital · 147d
Cleared Mar 03, 2003
MS PAED-BABY BODY
K023796 · CCM
Erich Jaeger GmbH
Anesthesiology · 110d
Cleared Mar 03, 2003
TENSCARE ULTIMA NMS/EMS
K023997 · IPF
Tenscare, Ltd.
Physical Medicine · 90d
Cleared Mar 03, 2003
XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM
K024004 · DZE
Friadent GmbH
Dental · 89d
Cleared Mar 03, 2003
ASCENSIA BREEZE BLOOD GLUCOSE METER
K024062 · CGA
Bayer Corp.
Chemistry · 84d
Cleared Mar 03, 2003
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS
K024182 · CDQ
Precision Systems, Inc.
Chemistry · 74d
Cleared Mar 03, 2003
PROMOTOR FINAL RINSE SPERM WASH MEDIUM
K024290 · MQL
Ceres Fertility, Inc.
Obstetrics & Gynecology · 70d
Cleared Mar 03, 2003
POWDER FREE VINYL EXAM GLOVES WITH ALOE COATING INSIDE
K024338 · LYZ
General Gloves Corp.
General Hospital · 66d
Cleared Mar 03, 2003
ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925
K030163 · EKX
Aseptico, Inc.
Dental · 46d
Cleared Mar 03, 2003
ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED
K030335 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 31d
Cleared Mar 03, 2003
TISSUELINK SEALING FORCEPS, MODEL 1 21-202-1
K030380 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 26d
Cleared Mar 03, 2003
BAYER LIGAND PLUS 1, 2, 3 CONTROLS
K030452 · JJY
Bayer Diagnostics Corp.
Chemistry · 20d
Cleared Mar 03, 2003
TITANIUM OSSICULAR REPLACMENT SYSTEM
K030492 · ETA
Invotec International, Inc.
Ear, Nose, Throat · 12d
Cleared Mar 03, 2003
CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING)...
K030524 · OBJ
Cd Leycom BV
Cardiovascular · 12d
Cleared Feb 28, 2003
SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800
K023083 · FRN
Mettler Electronics Corp.
General Hospital · 164d