Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
62425–62448 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 2006
AUTOBONE2
K061625 · JAK
Ge Healthcare
Radiology · 14d
Cleared Jun 23, 2006
EMJOI TENS DEVICE
K052711 · GZJ
Emjoi, Inc.
Neurology · 267d
Cleared Jun 23, 2006
AFIBALERT ATRIAL FIBRILLATION DETECTOR
K052767 · DXH
Lechnologies Research, Inc.
Cardiovascular · 266d
Cleared Jun 23, 2006
INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5
K052908 · DQO
Infraredx, Inc.
Cardiovascular · 252d
Cleared Jun 23, 2006
SPIDERX EMBOLIC PROTECTION DEVICE
K053195 · NFA
Ev3, Inc.
Cardiovascular · 220d
Cleared Jun 23, 2006
ZIMMER COLLAGEN REPAIR PATCH
K053562 · FTM
Tissue Science Laboratories, Plc
General & Plastic Surgery · 184d
Cleared Jun 23, 2006
OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13
K060243 · EOQ
Olympus Medical Systems Corporation
Ear, Nose, Throat · 143d
Cleared Jun 23, 2006
VS-800 VITAL SIGNS MONITOR
K060281 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 140d
Cleared Jun 23, 2006
COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
K060316 · LZH
Fresenius Kabi Deutschland GmbH
General Hospital · 135d
Cleared Jun 23, 2006
VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM
K060483 · IYO
Volcano Corporation
Radiology · 119d
Cleared Jun 23, 2006
PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING
K060509 · NYU
Tyco Healthcare Group
Gastroenterology & Urology · 116d
Cleared Jun 23, 2006
ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY
K060745 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 95d
Cleared Jun 23, 2006
PILOT TEST OR DETECTIVE AUDIOMETERS
K060883 · EWO
Interacoustics A/S
Ear, Nose, Throat · 84d
Cleared Jun 23, 2006
ACELL POWDER WOUND DRESSING
K060888 · KGN
Acell, Inc.
General & Plastic Surgery · 84d
Cleared Jun 23, 2006
SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND...
K060900 · OLW
Spacelabs Medical, Inc.
Neurology · 81d
Cleared Jun 23, 2006
BIPAP PLUS M-SERIES BI-LEVEL SYSTEM
K061034 · BZD
Respironics, Inc.
Anesthesiology · 70d
Cleared Jun 23, 2006
BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES,...
K061038 · KGO
Barriermed Glove Co.
General Hospital · 70d
Cleared Jun 23, 2006
BREAS ISLEEP 20+
K061057 · BZD
Breas Medical AB
Anesthesiology · 67d
Cleared Jun 23, 2006
CREATININE
K061193 · CGX
Abbott Laboratories, Inc.
Chemistry · 56d
Cleared Jun 23, 2006
EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222
K061254 · DWF
Medtronic Perfusion Systems
Cardiovascular · 50d
Cleared Jun 23, 2006
COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM
K061301 · JTW
Copan Diagnostics, Inc.
Microbiology · 44d
Cleared Jun 23, 2006
DIGITAL PRINTER P6000D SERIES, MODEL P6000DU
K061302 · LMC
Mitsubishi Electric Corporation Kyoto...
Radiology · 44d
Cleared Jun 23, 2006
CALSET COMPOSITE HEATER
K061395 · EBZ
Addent, Inc.
Dental · 35d
Cleared Jun 23, 2006
SMART USBLITE, MODEL M011120
K061443 · GWJ
Intelligent Hearing Systems
Neurology · 30d