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
71737–71760 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 2003
H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM
K014013 · FLF
H & W Technology, LLC
General Hospital · 567d
Cleared Jun 25, 2003
DETECTAR, MODEL N123-MI
K023367 · EJB
Neks Technologies
Dental · 260d
Cleared Jun 25, 2003
SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010
K023817 · MNW
Clio Designs, Inc.
Gastroenterology & Urology · 222d
Cleared Jun 25, 2003
IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE
K030035 · JFY
Diametrics Medical, Inc.
Chemistry · 173d
Cleared Jun 25, 2003
SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515
K030708 · NGX
Bio-Medical Research, Ltd.
Physical Medicine · 111d
Cleared Jun 25, 2003
DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR
K030990 · CAH
Datex-Ohmeda
General Hospital · 89d
Cleared Jun 25, 2003
MIRACLE 98
K031010 · EJT
Sb Lucius, Inc.
Dental · 86d
Cleared Jun 25, 2003
CALIBRATING MATERIAL, CALIBRATING STANDARDS
K031159 · JIT
Diamond Diagnostics, Inc.
Chemistry · 72d
Cleared Jun 25, 2003
QUANTA PLEX ENA PROFILE 6
K031450 · LLL
Inova Diagnostics, Inc.
Immunology · 49d
Cleared Jun 25, 2003
RAPIDO CUT-AWAY GUIDING CATHETER
K031505 · DQY
Guidant Corporation
Cardiovascular · 42d
Cleared Jun 25, 2003
BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL
K031644 · JJY
Bayer Healthcare, LLC
Chemistry · 29d
Cleared Jun 25, 2003
EBI XFIX DFS SYSTEM
K031645 · KTT
Ebi, L.P.
Orthopedic · 28d
Cleared Jun 25, 2003
LIPOPROTEIN CALIBRATOR
K031682 · JIX
Bayer Healthcare, LLC
Chemistry · 26d
Cleared Jun 25, 2003
ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY
K031756 · CGN
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Jun 25, 2003
DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES
K031781 · MHX
Datex-Ohmeda
Cardiovascular · 15d
Cleared Jun 24, 2003
ASYRA
K023355 · GZO
Galloway Technologies, LLC
Neurology · 260d
Cleared Jun 24, 2003
UF BRACHYTHERAPY STAND
K023430 · IYO
University of Florida
Radiology · 256d
Cleared Jun 24, 2003
BD VIPER INSTRUMENT
K023955 · JQW
Becton, Dickinson & CO
Microbiology · 209d
Cleared Jun 24, 2003
CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM...
K024270 · CAH
Intersurgical, Inc.
General Hospital · 183d
Cleared Jun 24, 2003
BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM
K030578 · NAY
Computer Motion, Inc.
General & Plastic Surgery · 120d
Cleared Jun 24, 2003
MODIFICATION TO COLORADO 2 SPINAL SYSTEM
K030875 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 96d
Cleared Jun 24, 2003
ECLIPSE
K030981 · LNH
Varian Medical Systems, Inc.
Radiology · 88d
Cleared Jun 24, 2003
MODIFICATION TO TRANSPORT INCUBATOR 185
K031096 · FPL
International Biomedics, Inc.
General Hospital · 78d
Cleared Jun 24, 2003
SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X
K031154 · JDW
Sintea Biotech, Inc.
Orthopedic · 74d