FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
23689–23712 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 2019
HEALIX Ti ANCHOR with DYNACORD
K183279 · MBI
Medos International SARL
Orthopedic · 90d
Cleared Feb 21, 2019
ZOOM Aspiration Pump
K190105 · JCX
Taiwan Biomaterial Co., Ltd.
General & Plastic Surgery · 30d
Cleared Feb 21, 2019
Sensus Healthcare TVM Balloon Applicator
K190255 · JAD
Sensus Healthcare, Inc.
Radiology · 14d
Cleared Feb 20, 2019
AnyCheck IMT-100
K180953 · EKX
Dms Co., Ltd.
Dental · 315d
Cleared Feb 20, 2019
MRIdian Linac System
K181989 · IYE
Viewray, Incorporated
Radiology · 209d
Cleared Feb 20, 2019
VITEK 2 AST-Gram Negative Imipenem (= 16 ug/mL)
K183415 · LON
bioMerieux, Inc.
Microbiology · 72d
Cleared Feb 19, 2019
Byte Aligner System
K180346 · NXC
Straight Smile, LLC
Dental · 376d
Cleared Feb 19, 2019
Pressure Therapy System PT1003
K181409 · IRP
Xiamen Senyang Co., Ltd.
Physical Medicine · 265d
Cleared Feb 19, 2019
MIS Bunion System
K181872 · HRS
Crossroads Extremity Systems, LLC
Orthopedic · 222d
Cleared Feb 19, 2019
Vector Hammertoe Correction System
K183055 · HWC
Nvision Biomedical Technologies, LLC
Orthopedic · 109d
Cleared Feb 19, 2019
BrainScope TBI (Model: Ahead 400)
K183241 · PIW
Brainscope Company, Inc.
Neurology · 90d
Cleared Feb 19, 2019
Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm
K183594 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 60d
Cleared Feb 17, 2019
TMS-Cobot TS MV
K182768 · QFF
Axilum Robotics
Neurology · 142d
Cleared Feb 16, 2019
Quo-Test A1c System
K180509 · LCP
Ekf Diagnostic GmbH
Chemistry · 354d
Cleared Feb 16, 2019
Wu's Powered Wheelchair
K181163 · ITI
Wu'S Tech Co., Ltd.
Physical Medicine · 291d
Cleared Feb 16, 2019
TEMA Elbow System
K181362 · JDC
Lima Corporate S.P.A.
Orthopedic · 269d
Cleared Feb 16, 2019
GEM Premier ChemSTAT
K183546 · CGA
Instrumentation Laboratory CO
Chemistry · 58d
Cleared Feb 16, 2019
GEM Premier ChemSTAT
K183549 · JGS
Instrumentation Laboratory CO
Chemistry · 58d
Cleared Feb 16, 2019
GEM Premier ChemSTAT
K183555 · JFY
Instrumentation Laboratory CO
Chemistry · 58d
Cleared Feb 16, 2019
RX-1 Rhythm Express Remote Cardiac Monitoring System
K183704 · DXH
Vivaquant, Inc.
Cardiovascular · 47d
Cleared Feb 15, 2019
SpiroSphere
K173937 · BTY
Eresearchtechnology GmbH
Anesthesiology · 416d
Cleared Feb 15, 2019
SmartMouth DryMouth Oral Rinse
K181194 · LFD
Triumph Pharmaceuticals, Inc.
Dental · 287d
Cleared Feb 15, 2019
Lunderquist® Fixed Core Wire Guide
K181353 · DQX
Cook Incorporated
Cardiovascular · 269d
Cleared Feb 15, 2019
Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP,...
K181393 · KPE
Valmed S.R.L.
General Hospital · 262d