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.

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

Filters: Cleared only ×
175,230 results
36769–36792 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 2014
HEMOSIL D-DIMER HS 500 CONTROL
K133582 · GGN
Instrumentation Laboratory
Hematology · 267d
Cleared Aug 15, 2014
AVACEN 100
K133981 · IRT
Avacen, Inc.
Physical Medicine · 232d
Cleared Aug 15, 2014
CORMATRIX PROTECT ECM ENVELOPE
K140306 · FTM
Cormatrix Cardiovascular, Inc.
General & Plastic Surgery · 189d
Cleared Aug 15, 2014
MASTERSURG / EXPERTSURG
K140308 · EBW
Kaltenbach & Voigt GmbH
Dental · 189d
Cleared Aug 15, 2014
ENDLESSFIBER REUSABLE SURGICAL LASER FIBER
K140366 · GEX
Hogue Surgical, LLC
General & Plastic Surgery · 182d
Cleared Aug 15, 2014
RESPICONNECT ADAPTER
K140919 · CAF
Trudell Medical Int'L
Anesthesiology · 127d
Cleared Aug 15, 2014
ALIVECOR HEART MONITOR
K140933 · DXH
AliveCor, Inc.
Cardiovascular · 126d
Cleared Aug 15, 2014
VONFLEX S BITE
K140966 · ELW
Vericom Co., Ltd.
Dental · 122d
Cleared Aug 15, 2014
NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER
K141090 · LOX
Medtronic, Inc.
Cardiovascular · 109d
Cleared Aug 15, 2014
EXACTECH CERVICAL SPACER SYSTEM
K141129 · ODP
Exactech, Inc.
Orthopedic · 106d
Cleared Aug 15, 2014
ARTHREX ANKLE FUSION PLATING SYSTEM
K141735 · HRS
Arthrex, Inc.
Orthopedic · 49d
Cleared Aug 15, 2014
DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE
K141951 · DWF
Medtronic, Inc.
Cardiovascular · 28d
Cleared Aug 14, 2014
SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM
K130720 · KCT
Synthes USA Products, LLC
General Hospital · 514d
Cleared Aug 14, 2014
OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM
K132633 · NBW
Ok Biotech Co., Ltd.
Chemistry · 357d
Cleared Aug 14, 2014
TEMPUS PRO WITH ENHANCED FEATURES
K133973 · QYW
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 231d
Cleared Aug 14, 2014
SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOMATOM EMOTION & SENSATION FAMILY CT
K140232 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 196d
Cleared Aug 14, 2014
ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS
K140508 · HRS
Zimmer, Inc.
Orthopedic · 167d
Cleared Aug 14, 2014
STRAUMANN CARES SCREW RETAINED BARS/BRIDGE
K140737 · NHA
Straumann USA, LLC
Dental · 143d
Cleared Aug 14, 2014
KIVA VCF TREATMENT SYSTEM
K141141 · NDN
Benvenue Medical, Inc.
Orthopedic · 104d
Cleared Aug 14, 2014
LIGASURE
K141153 · GEI
Covidien
General & Plastic Surgery · 101d
Cleared Aug 14, 2014
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
K141281 · KOC
Fresenius Medical Care Renal...
Gastroenterology & Urology · 90d
Cleared Aug 14, 2014
WHITNEY MEDICAL SOLUTIONS ESHIELD
K141438 · KKX
Whitney Medical Solutions
General Hospital · 76d
Cleared Aug 13, 2014
BUZZY
K130631 · PHW
Mmj Labs, LLC
Physical Medicine · 523d
Cleared Aug 13, 2014
0.9% SODIUM CHLORIDE FLUSH SYRINGE
K133685 · NGT
Am USA
General Hospital · 254d