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
39025–39048 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 2014
PHYSIOFLOW Q-LINK
K140102 · DSB
Vasocom, Inc.
Cardiovascular · 28d
Cleared Feb 12, 2014
RESTORELLE Y CONTOUR MESH
K140116 · OTO
Coloplast A/S
Obstetrics & Gynecology · 27d
Cleared Feb 11, 2014
GUAVA II
K122632 · DPS
Cardiocomm Solutions, Inc.
Cardiovascular · 531d
Cleared Feb 11, 2014
CONTROL SEAL
K130485 · EBC
Voco GmbH
Dental · 351d
Cleared Feb 11, 2014
JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD
K132472 · GDW
Justright Surgical, LLC
General & Plastic Surgery · 188d
Cleared Feb 11, 2014
EZ-IO INTRAOSSEOUS INFUSION SYSTEM
K132583 · FMI
Vidacare Corporation
General Hospital · 179d
Cleared Feb 11, 2014
SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP,...
K132925 · NKB
Amendia, Inc.
Orthopedic · 146d
Cleared Feb 11, 2014
DANA REUSABLE TEST PACK
K133267 · FRC
Dana Products, Inc.
General Hospital · 110d
Cleared Feb 11, 2014
ADHESE UNIVERSAL
K133318 · KLE
Ivoclar Vivadent, AG
Dental · 106d
Cleared Feb 11, 2014
ENDORINGS
K133359 · FED
Endo-Aid, Inc.
Gastroenterology & Urology · 103d
Cleared Feb 11, 2014
V8 TRANSLUMINAL BAV CATHETER
K133607 · OZT
Intervalve, Inc.
Cardiovascular · 78d
Cleared Feb 11, 2014
EQUINOXE EXTRA SHORT HUMERAL HEAD
K140063 · KWS
Exactech, Inc.
Orthopedic · 32d
Cleared Feb 11, 2014
AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY
K140117 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 26d
Cleared Feb 10, 2014
CITRISOL ACID CONCENTRATE
K130511 · KPO
Diasol, Inc.
Gastroenterology & Urology · 348d
Cleared Feb 10, 2014
NEXXZR(TM)T AND NEXXZR(TM)S
K130991 · EIH
Sagemax Bioceramics, Inc.
Dental · 306d
Cleared Feb 10, 2014
ARTASSIST AND VENASSIST
K131146 · JOW
Aci Medical, LLC
Cardiovascular · 293d
Cleared Feb 10, 2014
TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESIS
K133477 · HTY
Synchro Medical
Orthopedic · 90d
Cleared Feb 10, 2014
AQUILION ONE VISION
K133497 · JAK
Toshibamedical Systems Corporation
Radiology · 88d
Cleared Feb 10, 2014
OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070
K133583 · MAX
Interventional Spine, Inc.
Orthopedic · 81d
Cleared Feb 10, 2014
C-PLUS
K133623 · ODP
Pioneer Surgical Technology, Inc.
Orthopedic · 76d
Cleared Feb 10, 2014
IMRI 1.5T AND IMRI 3T S
K133692 · LNH
Imris, Inc.
Radiology · 70d
Cleared Feb 07, 2014
QUANTA FLASH CENTROMERE
K123880 · LJM
Inova Diagnostics, Inc.
Immunology · 417d
Cleared Feb 07, 2014
ALERTWATCH: OR
K130401 · MHX
Alertwatch, LLC
Cardiovascular · 353d
Cleared Feb 07, 2014
MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES,...
K130616 · KNW
Biopsybell S.R.L.
Gastroenterology & Urology · 337d