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

Filters: Cleared only ×
175,820 results
32785–32808 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 2016
2MP Color LCD Monitor, RadiForce RX250 and RX250-AR
K160247 · PGY
Eizo Corporation
Radiology · 22d
Cleared Feb 23, 2016
5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)
K160326 · PGY
Jvckenwood Corporation
Radiology · 18d
Cleared Feb 22, 2016
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
K153548 · HRX
Visionsense, Ltd.
Orthopedic · 73d
Cleared Feb 22, 2016
PriMatrix Dermal Repair Scaffold
K153690 · KGN
Tei Biosciences, Inc.
General & Plastic Surgery · 61d
Cleared Feb 19, 2016
Ora-GUARD Dental Grind Guard
K150492 · OBR
Bite Tech, Inc.
Dental · 359d
Cleared Feb 19, 2016
Venturi Gauze Wound Care Sets with Portal Drain
K151263 · OMP
Talley Group, Ltd.
General & Plastic Surgery · 282d
Cleared Feb 19, 2016
APEX Compounding System Transfer Set
K151423 · LHI
B.Braun Medical, Inc.
General Hospital · 267d
Cleared Feb 19, 2016
ATLANTIS ISUS
K151439 · NHA
Dentsply International, Inc.
Dental · 266d
Cleared Feb 19, 2016
Epix Electrosurgical Probe with Smoke Evacuation
K151480 · GEI
Applied Medical Resources
General & Plastic Surgery · 262d
Cleared Feb 19, 2016
Oscar 2
K151520 · DXN
Suntech Medical, Inc.
Cardiovascular · 259d
Cleared Feb 19, 2016
InMode RF System
K151793 · GEI
Inmode MD , Ltd.
General & Plastic Surgery · 233d
Cleared Feb 19, 2016
CPX 4 Breast Tissue Expander
K152496 · LCJ
Mentor Worldwide, LLC
General & Plastic Surgery · 171d
Cleared Feb 19, 2016
V20 system
K152611 · GEX
Viora , Ltd.
General & Plastic Surgery · 158d
Cleared Feb 19, 2016
Weely Manual Wheelchair
K152827 · IOR
Rupiani
Physical Medicine · 143d
Cleared Feb 19, 2016
ViziShot FLEX
K152922 · KTI
Spiration, Inc.
Ear, Nose, Throat · 140d
Cleared Feb 19, 2016
SmartBase for Arthrex Glenoid IRIS
K153215 · KWS
Custom Orthopaedic Solutions, Inc.
Orthopedic · 106d
Cleared Feb 19, 2016
syngo.CT Single Source Dual Energy (Twin Beam)
K153220 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 105d
Cleared Feb 19, 2016
FreeStyle Precision Neo H Blood Glucose Monitoring System
K153330 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 92d
Cleared Feb 19, 2016
Low Potassium Dextran Solution with Tris Diluent
K153384 · KDN
United Therapeutics Corporation
Gastroenterology & Urology · 88d
Cleared Feb 19, 2016
Arthrex iBalance TKA System
K153586 · MBH
Arthrex, Inc.
Orthopedic · 65d
Cleared Feb 19, 2016
InZone Detachment System
K160096 · HCG
Stryker Neurovascular
Neurology · 31d
Cleared Feb 19, 2016
I4 (Integrated Intelligent Imaging Informatics) system
K160315 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 14d
Cleared Feb 18, 2016
DBSWIN and VistaEasy Imaging Software
K143290 · LLZ
Durr Dental AG
Radiology · 458d
Cleared Feb 18, 2016
Arm automatic blood pressure monitor
K151258 · DXN
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 282d