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
32401–32424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 06, 2016
Wireless Earlens Light Driven Hearing Aid
K153634 · PLK
Earlens Corporation
Ear, Nose, Throat · 110d
Cleared Apr 06, 2016
SMR 3-Pegs Glenoids
K153722 · KWS
Lima Corporate S.P.A.
Orthopedic · 100d
Cleared Apr 06, 2016
EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System,...
K160807 · IYN
Philips Ultrasound, Inc.
Radiology · 13d
Cleared Apr 05, 2016
NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE
K151503 · PIF
Gbuk Enteral Limited
Gastroenterology & Urology · 306d
Cleared Apr 05, 2016
SleepWeaver Advance Pediatric Nasal CPAP Mask
K151683 · BZD
Circadiance, LLC
Anesthesiology · 288d
Cleared Apr 05, 2016
PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement
K152652 · EMA
Gaia Dental Products, Inc.
Dental · 202d
Cleared Apr 05, 2016
Disposable Temporary Pacing Cable
K152947 · DSA
Tiger Medical Products
Cardiovascular · 182d
Cleared Apr 05, 2016
ULTRA Telescopes
K153009 · EOB
Olympus Winter & Ibe GmbH
Ear, Nose, Throat · 174d
Cleared Apr 05, 2016
Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars
K153258 · NLM
Surgical Instrument Service and...
Gastroenterology & Urology · 147d
Cleared Apr 05, 2016
Non-Telescopic PenEvac
K160160 · GEI
I.C Medical, Inc.
General & Plastic Surgery · 69d
Cleared Apr 05, 2016
Barrx FLEX RFA Energy Generator
K160360 · GEI
Covidien, LLC
General & Plastic Surgery · 56d
Cleared Apr 05, 2016
EVO platform
K160368 · GEX
Quanta System Spa
General & Plastic Surgery · 56d
Cleared Apr 05, 2016
SonoSite SII Ultrasound System
K160734 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 19d
Cleared Apr 04, 2016
SMARTez elastomeric infusion pump
K151650 · MEB
Epic Medical Pte. , Ltd.
General Hospital · 291d
Cleared Apr 04, 2016
Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis...
K151967 · MSD
Merit Medical Systems, Inc.
Gastroenterology & Urology · 263d
Cleared Apr 04, 2016
Hydroven 12, Hydroven 12 Garments
K152228 · JOW
Huntleigh Healthcare , Ltd.
Cardiovascular · 241d
Cleared Apr 04, 2016
HG Pro Nitrile Powder Free Examination Gloves
K152479 · LZA
Healthy Glove Co., Ltd.
General Hospital · 217d
Cleared Apr 04, 2016
0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe
K153481 · NGT
Becton, Dickinson and Company
General Hospital · 123d
Cleared Apr 04, 2016
LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw...
K160124 · MNI
Spinevision S.A.
Orthopedic · 75d
Cleared Apr 04, 2016
S45 Digital Color Doppler Ultrasound System
K160283 · IYN
Sonoscape Medical Corp.
Radiology · 61d
Cleared Apr 04, 2016
PRECICE Intramedullary Limb Lengthening System
K160325 · HSB
Ellipse Technologies, Inc.
Orthopedic · 59d
Cleared Apr 04, 2016
Opticage(R) Expandable Interbody Fusion Device
K160464 · MAX
Interventional Spine, Inc.
Orthopedic · 45d
Cleared Apr 04, 2016
Acclarix LX8 Diagnostic Ultrasound System
K160790 · IYN
Edan Instruments, Inc.
Radiology · 13d
Cleared Apr 01, 2016
TRUE METRIX GO Self Monitoring Blood Glucose System
K143548 · NBW
Trividia Health, Inc.
Chemistry · 473d