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
60337–60360 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 16, 2007
MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR
K062464 · GEI
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 176d
Cleared Feb 16, 2007
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
K062567 · NBW
Bionime Corporation
Chemistry · 169d
Cleared Feb 16, 2007
SIDESTREAM PLUS
K062689 · CAF
Respironics , Ltd.
Anesthesiology · 158d
Cleared Feb 16, 2007
BETA-POWDER
K063236 · KOJ
Brainbase Corporation
Dental · 114d
Cleared Feb 16, 2007
CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR
K063349 · DXZ
Cormatrix Cardiovascular, Inc.
Cardiovascular · 102d
Cleared Feb 16, 2007
HEALADEX-P
K063517 · FRO
Healagenics, Inc.
General & Plastic Surgery · 87d
Cleared Feb 16, 2007
ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS
K063520 · OAV
Roche Diagnostics
Toxicology · 87d
Cleared Feb 16, 2007
ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10, 11, 13, 16
K063523 · DZE
Zimmer Dental, Inc.
Dental · 86d
Cleared Feb 16, 2007
POWDER FREE VINYL PATIENT EXAMINATION GLOVE
K070030 · LYZ
Super Safe Plastic Products Co., Ltd.
General Hospital · 44d
Cleared Feb 16, 2007
ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM
K070088 · NBW
Apex BioTechnology Corp.
Chemistry · 38d
Cleared Feb 16, 2007
DOWN PAK
K070246 · EKM
Endo Twinn B.V.
Dental · 22d
Cleared Feb 15, 2007
EXSEPT WC WOUND CLEANSER
K061467 · FRO
Alcavis International, Inc.
General & Plastic Surgery · 265d
Cleared Feb 15, 2007
BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230
K062603 · MNW
Biospace Corporation Limited
Gastroenterology & Urology · 167d
Cleared Feb 15, 2007
TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL
K062946 · GXI
Top Corp.
Neurology · 140d
Cleared Feb 15, 2007
PRISMA M10 PRE SET
K063183 · KDI
Gambro Renal Products, Inc.
Gastroenterology & Urology · 119d
Cleared Feb 15, 2007
SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800
K063404 · CBK
Maquet Critical Care AB
Anesthesiology · 98d
Cleared Feb 15, 2007
DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1...
K063425 · DGC
Dade Behring, Inc.
Immunology · 94d
Cleared Feb 15, 2007
VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840
K063650 · CBK
Puritan Bennett Corp.
Anesthesiology · 69d
Cleared Feb 15, 2007
DIMENSION VISTA
K063655 · CHN
Dade Behring, Inc.
Immunology · 69d
Cleared Feb 15, 2007
CO2 EASY
K070128 · CCK
Westmed, Inc.
Anesthesiology · 30d
Cleared Feb 15, 2007
RADIFORCE GX220 AND GS220 MONOCHROME LCD MONITORS
K070131 · LLZ
Eizo Nanao Corporation
Radiology · 30d
Cleared Feb 15, 2007
VASCUPUNCTURE PICC GUIDEWIRE
K070150 · DQX
Neometrics, Inc.
Cardiovascular · 30d
Cleared Feb 15, 2007
QUATTRO CATHETER MODEL IC4593
K070161 · NCX
Alsius Corp.
Neurology · 29d
Cleared Feb 15, 2007
TEMPORARY LIMB SALVAGE SHUNT
K070323 · DXC
Vascutek, Ltd.
Cardiovascular · 13d