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
28249–28272 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 2017
Sorbact Wound Dressing-Ribbon Gauze
K171225 · FRO
Abigo Medical AB
General & Plastic Surgery · 117d
Cleared Aug 21, 2017
Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with...
K171276 · KGO
Tg Medical Sdn. Bhd.
General Hospital · 112d
Cleared Aug 21, 2017
MAMBA and MAMBA FLEX Microcatheters
K171452 · DQY
Boston Scientific Corporation
Cardiovascular · 96d
Cleared Aug 21, 2017
Ceribell Instant EEG Headband
K171459 · GXY
Ceribell, Inc.
Neurology · 95d
Cleared Aug 21, 2017
RIDA GENE Norovirus GI/GII
K171511 · PIQ
R-Biopharm AG
Microbiology · 89d
Cleared Aug 21, 2017
Zenius™, lliad™ and Kora™ Spinal Fixation Systems
K171526 · NKB
Medyssey USA, Inc.
Orthopedic · 88d
Cleared Aug 21, 2017
Approach CTO Microwire Guide
K171897 · DQX
Cook Incorporated
Cardiovascular · 56d
Cleared Aug 21, 2017
Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation...
K172107 · NKB
Spineology, Inc.
Orthopedic · 40d
Cleared Aug 18, 2017
s LDL-EX SEIKEN
K161679 · PYP
Denka Seiken Co., Ltd.
Chemistry · 427d
Cleared Aug 18, 2017
ARK Methotrexate Assay
K163359 · LAO
ARK Diagnostics, Inc.
Toxicology · 261d
Cleared Aug 18, 2017
Diazyme DZ-Lite Total beta-hCG Test System
K163418 · DHA
Diazyme Laboratories
Chemistry · 255d
Cleared Aug 18, 2017
Zip 4 Skin Closure Device
K170003 · PYO
Zipline Medical, Inc.
General & Plastic Surgery · 227d
Cleared Aug 18, 2017
3DMetal Tibial Cones
K170149 · JWH
Medacta International S.A.
Orthopedic · 213d
Cleared Aug 18, 2017
CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill...
K170431 · DXT
Coeur, Inc.
Cardiovascular · 186d
Cleared Aug 18, 2017
QEVO System with KINEVO 900
K170667 · GWG
Carl Zeiss Meditec, AG
Neurology · 165d
Cleared Aug 18, 2017
Medline UNITE® Snap-Off Screws
K170782 · HWC
Medline Industries, Inc.
Orthopedic · 156d
Cleared Aug 18, 2017
NuVasive LessRay with Enhanced Tracking
K170800 · OWB
Nu Vasive, Incorporated
Radiology · 154d
Cleared Aug 18, 2017
SnoreRx
K170825 · LRK
Apnea Sciences Corporation
Dental · 151d
Cleared Aug 18, 2017
Relievant Medsystems RF Generator
K171143 · GXD
Relievant Medsystems
Neurology · 122d
Cleared Aug 18, 2017
OmniTom
K171183 · JAK
Neurologica Corporation
Radiology · 116d
Cleared Aug 18, 2017
StarWalker
K171227 · GEX
Fotona D.O.O.
General & Plastic Surgery · 114d
Cleared Aug 18, 2017
ScannerSide DoseCheck
K171261 · JAK
Right Dose, Inc.
Radiology · 109d
Cleared Aug 18, 2017
Optum TeleHealth Application
K171406 · DRG
United Health Group, Inc.
Cardiovascular · 98d
Cleared Aug 18, 2017
ExsoMed ArcPhix and ExsoMed ArrowPhix
K171407 · HWC
Exsomed Holding Company, LLC
Orthopedic · 98d