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
32713–32736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 2016
Wrist 3
K160185 · LNH
Aspect Imaging, Ltd.
Radiology · 34d
Cleared Mar 01, 2016
VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm
K160230 · GCJ
Covidien
General & Plastic Surgery · 29d
Cleared Feb 29, 2016
Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs
K150468 · HAE
K2 Medical GmbH & Co. KG
Neurology · 371d
Cleared Feb 29, 2016
ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite
K150597 · DHB
Phadia AB
Immunology · 357d
Cleared Feb 29, 2016
BlastGen
K152932 · MQL
Origio A/S
Obstetrics & Gynecology · 147d
Cleared Feb 29, 2016
Prevena Plus Incision Management System Kit with Peel & Place Dressing,...
K153199 · OMP
Kci USA, Inc.
General & Plastic Surgery · 119d
Cleared Feb 29, 2016
syngo.via MI Workflows
K160317 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 24d
Cleared Feb 26, 2016
ICONACY(TM) I-Hip (TM)
K151307 · LZO
Iconacy Orthopedic Implants, LLC
Orthopedic · 284d
Cleared Feb 26, 2016
Beactive Brace
K151476 · PMV
Natures Pillows, Inc.
Physical Medicine · 269d
Cleared Feb 26, 2016
BCR-30-min BI™ and RBIP-ST30™ Readout Accessory
K151482 · FRC
Bcr Diagnostics, Inc.
General Hospital · 269d
Cleared Feb 26, 2016
THUNDERBEAT Open Fine Jaw
K151743 · GEI
Olympus Medical Systems Corp.
General & Plastic Surgery · 242d
Cleared Feb 26, 2016
Vesocclude Polymer Ligating Clip
K152082 · FZP
Vesocclude Medical, LLC
General & Plastic Surgery · 214d
Cleared Feb 26, 2016
Indego
K152416 · PHL
Parker Hannifin Corporation
Neurology · 184d
Cleared Feb 26, 2016
H3+ Holter Recorder
K152626 · MWJ
Mortara Instrument, Inc.
Cardiovascular · 164d
Cleared Feb 26, 2016
VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM
K152765 · DTK
B. Braun Interventional Systems, Inc.
Cardiovascular · 155d
Cleared Feb 26, 2016
VIVIX-S 1012N
K152855 · MQB
Vieworks Co., Ltd.
Radiology · 150d
Cleared Feb 26, 2016
VIVIX-S 1717N
K152894 · MQB
Vieworks Co., Ltd.
Radiology · 149d
Cleared Feb 26, 2016
Calcium Bridge
K153191 · EBF
Denali Corporation
Dental · 115d
Cleared Feb 26, 2016
Aingeal Activity System
K153275 · MHX
Intelesens, Ltd.
Cardiovascular · 106d
Cleared Feb 26, 2016
TandemLung Oxygenator
K153295 · DTZ
Cardiacassist, Inc.
Cardiovascular · 105d
Cleared Feb 26, 2016
E-CUBE i7
K153424 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 93d
Cleared Feb 26, 2016
Tyber Medical Trauma Screw
K153575 · HWC
Tyber Medical, LLC
Orthopedic · 73d
Cleared Feb 26, 2016
Sniper (R) Spine System
K160003 · MNI
Spine Wave, Inc.
Orthopedic · 53d
Cleared Feb 26, 2016
Illuminated Mediastinal Access Port
K160171 · EWY
Aegis Surgical, Ltd.
Ear, Nose, Throat · 30d