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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
36649–36672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 2014
DRAEGER JAUNDICE METER JM-105
K133175 · MQM
Draeger Medical Systems, Inc.
Chemistry · 392d
Cleared Nov 13, 2014
SYNGO, CT LIVER ANALYSIS
K133643 · JAK
Siemens Medi Cal Solutions, Inc.
Radiology · 351d
Cleared Nov 13, 2014
REJUVALITE MD
K133896 · OHS
Trophy Skin, Inc.
General & Plastic Surgery · 328d
Cleared Nov 13, 2014
VERAPLUG
K140352 · LZU
Krishna Imports Inc Dba Stephens...
Ophthalmic · 274d
Cleared Nov 13, 2014
OMNIPOD INSULIN MANAGEMENT SYSTEM
K140439 · LZG
Insulet Corporation
General Hospital · 265d
Cleared Nov 13, 2014
PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS...
K140466 · DXO
St. Jude Medical Systems AB
Cardiovascular · 262d
Cleared Nov 13, 2014
NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE
K140492 · MSD
Marvao Medical Devices, Ltd.
Gastroenterology & Urology · 259d
Cleared Nov 13, 2014
UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH
K141593 · GCJ
Unimicro Medical Systems (Shenzhen)...
General & Plastic Surgery · 153d
Cleared Nov 13, 2014
INTERNAL HYDRATING GEL
K141718 · NUC
Combe Incorporated
Obstetrics & Gynecology · 141d
Cleared Nov 13, 2014
MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM
K141989 · OLO
Mako Surgical Corporation
Orthopedic · 114d
Cleared Nov 13, 2014
AERO-LL LUMBAR CAGE SYSTEM
K142066 · OVD
Stryker Corporation
Orthopedic · 106d
Cleared Nov 13, 2014
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL...
K142115 · NHA
Prismatik Dentalcraft, Inc.
Dental · 101d
Cleared Nov 13, 2014
GammaBeam 100
K142219 · IWB
Best Theratronics Limited
Radiology · 93d
Cleared Nov 13, 2014
CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS...
K142254 · DQX
St Jude Medical
Cardiovascular · 91d
Cleared Nov 13, 2014
ONE Snare Endovascular Microsnare System
K142265 · MMX
Merit Medical Systems, Inc.
Cardiovascular · 90d
Cleared Nov 13, 2014
Shock Pulse-SE Lithotripsy System CYBERWAND II
K142428 · FEO
Cybersonics, Inc.
Gastroenterology & Urology · 76d
Cleared Nov 13, 2014
Barricade Embolization Coil System
K142513 · HCG
Blockade Medical
Neurology · 66d
Cleared Nov 13, 2014
Biomet Headless Compression and Twist-off Screws
K142658 · HWC
Biomet Manufacturing Corp
Orthopedic · 56d
Cleared Nov 12, 2014
HEALTH EXPERT ELCTRONIC STIMULATOR
K133929 · NUH
Shenzhen Osto Technology Company Limited
Neurology · 324d
Cleared Nov 12, 2014
COMPOSITE ORTHODONTIC BRACKETS
K140807 · DYW
Ortho Specialties
Dental · 225d
Cleared Nov 12, 2014
HIOSSEN IMPLANT SYSTEM
K140934 · DZE
Hiossen, Inc.
Dental · 215d
Cleared Nov 12, 2014
ANT MODEL 1
K141038 · KXK
Advanced Nuclide Technologies, LLC
Radiology · 204d
Cleared Nov 12, 2014
DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS
K141457 · NHA
Dentium Co., Ltd.
Dental · 163d
Cleared Nov 12, 2014
ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM
K141571 · HSB
Orthofix Srl
Orthopedic · 153d