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
43777–43800 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 2012
COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123...
K111188 · CHL
Roche Diagnostics
Chemistry · 383d
Cleared May 14, 2012
TINA-QUANT ALBUMIN GEN.2
K113072 · DCF
Roche Diagnostics Operations
Toxicology · 210d
Cleared May 14, 2012
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR
K113194 · LYZ
Suqian Ruijang Medical Supplies Co.,...
General Hospital · 196d
Cleared May 14, 2012
MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY
K113215 · MUD
Nonin Medical, Inc.
Cardiovascular · 195d
Cleared May 14, 2012
GEL-BLOCK EMBOLIZATION PLEDGETS
K113266 · KRD
Vascular Solutions, Inc.
Cardiovascular · 192d
Cleared May 14, 2012
COMED K-SERIES MANUAL WHEELCHAIR
K120077 · IOR
Danyang Comed Healthcare Co., Ltd.
Physical Medicine · 125d
Cleared May 14, 2012
ROCAMED ROCAUS PLATINUM
K120160 · KNY
Promepla Sam
Gastroenterology & Urology · 116d
Cleared May 14, 2012
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
K120166 · IRP
Won Industrial Co.
Physical Medicine · 116d
Cleared May 14, 2012
MLS, ZERONA-AD
K120257 · OLI
Erchonia Medical, Inc.
General & Plastic Surgery · 108d
Cleared May 14, 2012
EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL
K120497 · LCP
Medica Corp.
Chemistry · 83d
Cleared May 14, 2012
SYNTHES USS CONNECTOR
K120571 · NKB
Synthes Spine
Orthopedic · 77d
Cleared May 14, 2012
LATEX EXAMINATION GLOVES (POWDER FREE)
K120692 · LYY
Top Calibre Sdn Bhd
General Hospital · 68d
Cleared May 14, 2012
SR PHONARES II
K120736 · ELM
Ivoclar Vivadent, AG
Dental · 66d
Cleared May 14, 2012
DISPOSABLE POWER FREE VINYL EXAM GLOVE, PINK COLOR
K120798 · LYZ
Canopus Medical Supply Co., Ltd.
General Hospital · 60d
Cleared May 13, 2012
SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS
K121127 · GEX
Cynosure, Inc.
General & Plastic Surgery · 30d
Cleared May 11, 2012
DOBBHOFF DUAL PORT FEEDING TUBE
K112511 · KNT
Covidien Lp, Formerly Registered AS...
Gastroenterology & Urology · 255d
Cleared May 11, 2012
TATTOOSTAR EFFECT Y
K112669 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 240d
Cleared May 11, 2012
KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS
K113333 · BTR
Kimberly Clark Corporation
Anesthesiology · 179d
Cleared May 11, 2012
ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
K120057 · HLI
Bioptigen, Inc.
Ophthalmic · 123d
Cleared May 11, 2012
SUNMED GUIDE WIRE
K120119 · DQX
Sunny Medical Device (Shenzhen) Co.,...
Cardiovascular · 115d
Cleared May 11, 2012
ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM
K120183 · NBW
Broadmaster Biotech Corperation
Chemistry · 109d
Cleared May 11, 2012
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND...
K120185 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 109d
Cleared May 11, 2012
TROJAN MAGNUM CONDOM WITH WARMING LUBRICANT
K120249 · HIS
Church & Dwight Virginia Co., Inc.
Obstetrics & Gynecology · 105d
Cleared May 11, 2012
CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER
K120296 · DQY
St. Jude Medical, Cardiac Rhythm...
Cardiovascular · 101d