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
31465–31488 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 2016
IonoStar Plus
K160774 · EMA
Voco GmbH
Dental · 135d
Cleared Aug 03, 2016
AFX™ Femoral Implant With Inserter
K161033 · MBI
Cayenne Medical, Inc.
Orthopedic · 112d
Cleared Aug 03, 2016
CASSI II Rotational Core Biopsy System
K161234 · KNW
Scion Medical Technologies, LLC
Gastroenterology & Urology · 93d
Cleared Aug 03, 2016
DURAFIBER Ag
K161289 · FRO
Smith & Nephew Medical Limited
General & Plastic Surgery · 86d
Cleared Aug 03, 2016
DyeVert NG Contrast Modulation System
K161505 · DXT
Osprey Medical, Inc.
Cardiovascular · 63d
Cleared Aug 02, 2016
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low...
K151824 · LZA
Kossan International Sdn Bhd
General Hospital · 393d
Cleared Aug 02, 2016
Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use...
K160467 · LZA
Kossan International Sdn Bhd
General Hospital · 165d
Cleared Aug 02, 2016
5.0 Fr Arndt Endobronchial Blocker Set
K160542 · CBI
Cook Incorporated
Anesthesiology · 158d
Cleared Aug 02, 2016
Powder free vinyl patient examination glove, colored (yellow)
K160675 · LYZ
Kaixing Plastic Products Co., Litd.
General Hospital · 145d
Cleared CT Aug 02, 2016
ARIES® Flu A/B & RSV Assay
K161220 · OCC
Luminex Corporation
Microbiology · 95d
Cleared Aug 02, 2016
M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle...
K161409 · KNW
Mermaid Medical A/S
Gastroenterology & Urology · 74d
Cleared Aug 02, 2016
ARIX Foot System
K161864 · HRS
Jeil Medical Corporation
Orthopedic · 26d
Cleared Aug 02, 2016
Biomet Microfixation Sternal Closure System
K161896 · HRS
Biomet Microfixation
Orthopedic · 22d
Cleared Aug 01, 2016
The Hammertoe Correction System
K153065 · HWC
Life Spine, Inc.
Orthopedic · 284d
Cleared Aug 01, 2016
IDSS ForceTriad Control Module
K153205 · ODA
Black Diamond Video, Inc.
Gastroenterology & Urology · 271d
Cleared Aug 01, 2016
Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody...
K153352 · OVE
Spinal Elements, Inc.
Orthopedic · 255d
Cleared CT Aug 01, 2016
Fuse Endoscopic System with FuseBox Processor
K160275 · PEA
Endochoice, Inc.
Gastroenterology & Urology · 181d
Cleared Aug 01, 2016
Precision Point Biopsy Needle Guide
K160414 · ITX
Corbin Clinical Resources, LLC
Radiology · 167d
Cleared Aug 01, 2016
Aqueduct 100 Cervical Dilator
K160664 · PON
Gtimd, LLC
Obstetrics & Gynecology · 145d
Cleared Aug 01, 2016
VIRTU Lumbar Spacer System
K160699 · MAX
Met 1 Technologies, LLC
Orthopedic · 140d
Cleared Aug 01, 2016
SpineView X-Pac Expandable Lumbar Cage System
K160856 · MAX
Spine View, Inc.
Orthopedic · 126d
Cleared Aug 01, 2016
8ch Foot Ankle Coil
K160932 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 119d
Cleared Aug 01, 2016
Senolris
K160937 · LLZ
Ge Healthcare
Radiology · 119d
Cleared Aug 01, 2016
SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily...
K160938 · HQD
Synergeyes, Inc.
Ophthalmic · 119d