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

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175,820 results
40369–40392 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 2013
ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
K131363 · NBW
Cilag GmbH International
Chemistry · 109d
Cleared Aug 30, 2013
SUS (STENFILCON A) CONTACT LENS
K131378 · LPL
CooperVision, Inc.
Ophthalmic · 108d
Cleared Aug 30, 2013
CLEARFIL DC ACTIVATOR
K131430 · KLE
Kuraray Noritake Dental, Inc.
Dental · 105d
Cleared Aug 30, 2013
RESTORE MODULAR STERILIZATION TRAY SYSTEM
K131455 · KCT
Restore Medical Solutions, Inc.
General Hospital · 102d
Cleared Aug 30, 2013
PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3,...
K131558 · DXN
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 92d
Cleared Aug 30, 2013
OPTIMA CT660
K131576 · JAK
Ge Medical Systems, LLC
Radiology · 91d
Cleared Aug 30, 2013
RANGE SPINAL SYSTEM
K131784 · OSH
K2m, Inc.
Orthopedic · 73d
Cleared Aug 30, 2013
VITAL SIGNS MONITOR
K131818 · DQA
Edan Instruments, Inc.
Anesthesiology · 71d
Cleared Aug 30, 2013
SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT...
K132146 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 50d
Cleared Aug 30, 2013
UTF STEM-REDUCED, ADDITIONAL SIZES
K132207 · LPH
United Orthopedic Corporation
Orthopedic · 45d
Cleared Aug 30, 2013
ReVive PV (Peripheral Vasculature) Thrombectomy Device
K132281 · QEW
Codman & Shurtleff, Inc.
Cardiovascular · 38d
Cleared Aug 30, 2013
MRI PATIENT MONITORING SYSTEM
K132359 · MWI
Invivo Corporation
Cardiovascular · 31d
Cleared Aug 30, 2013
BAYLIS MEDICAL RF PERFORATION PROBE V2.0
K132374 · GEI
Baylis Medical Company, Inc.
General & Plastic Surgery · 31d
Cleared Aug 29, 2013
MEDISIZE GOLD HEATER AND BOOSTER T-PIECE
K122885 · BTT
Medisize BV
Anesthesiology · 343d
Cleared Aug 29, 2013
SYNGO CT PULMO 3D
K123540 · JAK
Siemens Medical Systems, Inc.
Radiology · 283d
Cleared Aug 29, 2013
ARCHITECT IVANCOMYCIN
K123947 · LEH
Biokit, S.A.
Toxicology · 251d
Cleared Aug 29, 2013
MAVEN PRO
K130242 · LLZ
Nsequence
Radiology · 210d
Cleared Aug 29, 2013
ENDOWRIST ONE VESSEL SEALER
K130266 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 206d
Cleared Aug 29, 2013
OMNI-VUE 2 SYSTEM
K130374 · LLZ
Genesis Digital Imaging, Inc.
Radiology · 196d
Cleared Aug 29, 2013
ENSITE VELOCITY SYSTEM
K130727 · DQK
St Jude Medical
Cardiovascular · 164d
Cleared Aug 29, 2013
NUVASIVE DECADE LATERAL PLATE SYSTEM
K130868 · KWQ
Nuvasive, Inc.
Orthopedic · 153d
Cleared Aug 29, 2013
ASPIRON ACP SYSTEM
K131200 · KWQ
U&I Corporation
Orthopedic · 122d
Cleared Aug 29, 2013
OMNIPOD INSULIN MANAGEMENT SYSTEM
K131294 · LZG
Insulet Corporation
General Hospital · 115d
Cleared Aug 29, 2013
CR 12-X DIGITIZER
K131408 · MQB
Agfa Healthcare N.V.
Radiology · 106d