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
31561–31584 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 2016
BostonSight PD Prosthetic Device
K161461 · HQD
Bostonsight
Ophthalmic · 60d
Cleared Jul 23, 2016
Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads,...
K161154 · NHI
Spr Therapeutics, LLC
Neurology · 89d
Cleared Jul 22, 2016
Sheath Introducer
K150932 · DRE
Bioteque Corp.
Cardiovascular · 473d
Cleared Jul 22, 2016
ST Internal Fixture System
K152787 · DZE
T-Plus Implant Tech. Co., Ltd.
Dental · 301d
Cleared Jul 22, 2016
ELAN 4 Motor System
K152960 · HBC
Aesculap, Inc.
Neurology · 289d
Cleared Jul 22, 2016
ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm...
K153267 · MQL
Origio A/S
Obstetrics & Gynecology · 253d
Cleared Jul 22, 2016
Braemar Telemetry Patch System
K153473 · DSI
Braemar Manufacturing, LLC
Cardiovascular · 233d
Cleared Jul 22, 2016
URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
K160372 · JIL
Teco Diagnostics, Inc.
Chemistry · 163d
Cleared Jul 22, 2016
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K160908 · FRG
STERIS Corporation
General Hospital · 112d
Cleared Jul 22, 2016
ReWalk(TM)
K160987 · PHL
Rewalk Robotics, Inc.
Neurology · 105d
Cleared Jul 22, 2016
Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4
K161009 · JAK
Toshibamedical Systems Corporation
Radiology · 102d
Cleared Jul 22, 2016
K2M Growing Spine System
K161028 · PGM
K2m, Inc.
Orthopedic · 101d
Cleared Jul 22, 2016
LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set
K161139 · LYR
DiaSorin, Inc.
Microbiology · 91d
Cleared Jul 22, 2016
Gianturco-Roehm Bird’s Nest Vena Cava Filter
K161218 · DTK
Cook Incorporated
Cardiovascular · 84d
Cleared Jul 22, 2016
KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
K161951 · PNI
Kronus, Inc.
Immunology · 7d
Cleared Jul 21, 2016
Dakin's Skin and Wound Cleanser
K150208 · FRO
Century Pharmaceuticals, Inc.
General & Plastic Surgery · 538d
Cleared Jul 21, 2016
ET III Bio-SA Fixture System
K151626 · DZE
Hiossen, Inc.
Dental · 400d
Cleared Jul 21, 2016
BioHPP - breCAM.BioHPP
K152113 · EBF
Bredent GmbH & Co. KG
Dental · 358d
Cleared Jul 21, 2016
GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle
K152913 · DYB
Creganna Medical Aslo Business AS...
Cardiovascular · 293d
Cleared Jul 21, 2016
PathLoc-C Posterior Cervical Fixation System
K153439 · NKG
L & K Biomed Co., Ltd.
Orthopedic · 237d
Cleared Jul 21, 2016
INTRAcel Premium Fractional RF Micro Needle (FRM) System
K153727 · GEI
Jeisys Medical, Inc.
General & Plastic Surgery · 206d
Cleared Jul 21, 2016
SHOFU Enamel Conditioner
K160086 · EBF
Shofu Dental Corporation
Dental · 188d
Cleared Jul 21, 2016
rainbow LS Block
K160144 · EIH
Genoss Co., Ltd.
Dental · 182d
Cleared Jul 21, 2016
SculpSure
K160470 · PKT
Cynosure, Inc.
General & Plastic Surgery · 153d