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
50209–50232 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 2010
HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS
K093466 · IYO
Hitachi Medical Systems America, Inc.
Radiology · 223d
Cleared Jun 17, 2010
EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E,...
K093619 · ESW
Cook Ireland, Ltd.
Gastroenterology & Urology · 206d
Cleared Jun 17, 2010
HASKAL TORQUE DEVICE
K100425 · DQX
Elcam Medical Acal
Cardiovascular · 121d
Cleared Jun 17, 2010
PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE
K100539 · EJR
Preventive Technologies, Inc.
Dental · 112d
Cleared Jun 17, 2010
R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100
K100861 · HLI
Optovue, Inc.
Ophthalmic · 83d
Cleared Jun 17, 2010
GYRUS ACMI HALO PKS CUTTING FORCEPS
K100896 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 78d
Cleared Jun 17, 2010
ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS
K101017 · LJT
AngioDynamics, Inc.
General Hospital · 66d
Cleared Jun 17, 2010
FIDUCIAL MARKERS
K101131 · IYE
Cosman Medical, Inc.
Radiology · 56d
Cleared Jun 17, 2010
PATCHASSIST
K101218 · ORQ
Polytouch Medical, Ltd.
General & Plastic Surgery · 48d
Cleared Jun 17, 2010
V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002
K101259 · MWI
Taidoc Technology Corporation
Cardiovascular · 44d
Cleared Jun 17, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
K101362 · LYZ
Hebei Handform Plastic Products Co.,...
General Hospital · 34d
Cleared Jun 17, 2010
COAXIAL INTRODUCER SET
K101399 · DYB
Martech Medical Products
Cardiovascular · 30d
Cleared Jun 17, 2010
T2 GREATER TROCHANTER NAIL
K101438 · HSB
Howmedica Osteonics Corp.
Orthopedic · 24d
Cleared Jun 17, 2010
CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE
K101523 · JOW
Devon Medical, Inc.
Cardiovascular · 15d
Cleared Jun 16, 2010
10 X 10 VISION
K091928 · MWP
Bioptics, Inc.
Radiology · 351d
Cleared Jun 16, 2010
POLYBONE DENTAL
K092194 · LYC
Kyung Won Medical Co., Ltd.
Dental · 330d
Cleared Jun 16, 2010
COLLAWOUND ART
K093351 · FRO
Collamatrix, Inc.
General & Plastic Surgery · 232d
Cleared Jun 16, 2010
ROBINSON MEDSURG QUICKSCREW RACK
K093800 · KCT
Robinson Medsurg, LLC
General Hospital · 188d
Cleared Jun 16, 2010
OLYMPIC BRAINZ MONITOR MODEL OBM70001
K093949 · OMA
Natus Medical, Inc.
Neurology · 175d
Cleared Jun 16, 2010
COROENT XLR STANDALONE SYSTEM
K100043 · OVD
Nuvasive, Inc.
Orthopedic · 159d
Cleared Jun 16, 2010
ASCENSION ANKLE FUSION PLATE SYSTEM
K100176 · HRS
Ascension Orthopedics, Inc.
Orthopedic · 146d
Cleared Jun 16, 2010
OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE...
K100815 · DQA
Oxypulse
Anesthesiology · 85d
Cleared Jun 16, 2010
CLEARPOINT SYSTEM
K100836 · ORR
Surgivision, Inc.
Radiology · 84d
Cleared Jun 16, 2010
CHEVEUX DIODE LASER SYSTEM
K100893 · GEX
Sandstone Medical Technologies, LLC
General & Plastic Surgery · 77d