Search FDA 510(k) Database

7,157 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
22393–22416 of 174,061
Cleared Dec 17, 2018
Phoenix 2.4mm Atherectomy Plus System
K181877 · MCW
Volcano Atheromed, Inc.
Cardiovascular · 157d
Cleared Dec 17, 2018
Acucy Influenza A&B Test with the Acucy System
K182001 · PSZ
SEKISUI Diagnostics, LLC
Microbiology · 144d
Cleared Dec 17, 2018
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
K182387 · FMF
Novo Nordisk, Inc.
General Hospital · 104d
Cleared Dec 17, 2018
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
K182433 · DXQ
Shenzhen Caremed Medical Technology...
Cardiovascular · 102d
Cleared Dec 17, 2018
FlowTriever Retrieval/Aspiration System
K183198 · QEW
Inari Medical
Cardiovascular · 28d
Cleared Dec 17, 2018
Reusable Silicone Cover CPRmeter 2
K183348 · LIX
Laerdal Medical AS
Cardiovascular · 14d
Cleared Dec 14, 2018
SCIg60 Infusion System
K173783 · PKP
Emed Technologies Corporation
General Hospital · 366d
Cleared Dec 14, 2018
CAPI 3 HEMOGLOBIN(E)
K180762 · GKA
Sebia
Hematology · 266d
Cleared Dec 14, 2018
Arthrex SwiveLock Anchors
K180768 · MAI
Arthrex, Inc.
Orthopedic · 266d
Cleared Dec 14, 2018
Xcess Guiding Catheter
K180797 · DQY
Curatia Medical Co.
Cardiovascular · 262d
Cleared Dec 14, 2018
Tono Vue Non-Contact Tonometer
K180820 · HKX
Crystalvue Medical Corporation
Ophthalmic · 260d
Cleared Dec 14, 2018
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid...
K180879 · DKZ
Shanghai Venture Bio-Tech Co., Ltd.
Toxicology · 255d
Cleared Dec 14, 2018
iCertainty
K181269 · DPW
Rfpi
General & Plastic Surgery · 214d
Cleared Dec 14, 2018
Honda Walking Assist Device
K181294 · PHL
Honda Motor Company, Ltd.
Neurology · 212d
Cleared Dec 14, 2018
C.T.M Mobility Scooter
K181344 · INI
Chien TI Enterprise Co., Ltd.
Physical Medicine · 207d
Cleared Dec 14, 2018
NRFit Syringe
K181374 · QEH
Jiangsu Caina Medical Co.,Ltd
General Hospital · 204d
Cleared Dec 14, 2018
Affixus Natural Nail System Humeral Nail
K181827 · HSB
Zimmer GmbH
Orthopedic · 158d
Cleared Dec 14, 2018
Acu-sInQ Complete Endoscope Cleaning Aid System
K181865 · FEB
STERIS Corporation
General Hospital · 155d
Cleared Dec 14, 2018
Phasix ST Mesh with Echo 2 Positioning System
K182008 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 140d
Cleared Dec 14, 2018
UV Active Implant System
K182194 · DZE
Dio Corporation
Dental · 122d
Cleared Dec 14, 2018
TR90BH
K182207 · IZL
Minxray, Inc.
Radiology · 121d
Cleared Dec 14, 2018
HyperFil-LV
K182296 · EBF
Parkell, Inc.
Dental · 112d
Cleared Dec 14, 2018
SafeAir Telescopic Smoke Pencil
K182354 · GEI
Lina Medical Aps
General & Plastic Surgery · 107d
Cleared Dec 14, 2018
Centricity Universal Viewer
K182419 · LLZ
Ge Healthcare
Radiology · 100d