Search FDA 510(k) Database

6,926 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
17545–17568 of 174,061
Cleared Aug 24, 2020
Dynex Ring Fixation System, Diametrix Ring Fixation System
K202054 · KTT
Vilex, LLC
Orthopedic · 31d
Cleared Aug 22, 2020
Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control...
K201505 · OCC
Diasorin Molecular, LLC
Microbiology · 78d
Cleared Aug 21, 2020
BTL-785F
K193201 · GEI
Btl
General & Plastic Surgery · 275d
Cleared Aug 21, 2020
U-Cem Premium & MAZIC Cem
K193260 · EMA
Vericom Co., Ltd.
Dental · 269d
Cleared Aug 21, 2020
4K UHD Camera System
K200216 · HET
Scivita Medical Technology Co., Ltd.
Obstetrics & Gynecology · 206d
Cleared Aug 21, 2020
Brainsway Deep TMS System
K200957 · QMD
Brainsway , Ltd.
Neurology · 134d
Cleared Aug 21, 2020
NeuroBlate System
K201056 · GEX
Monteris Medical, Inc.
Neurology · 122d
Cleared Aug 21, 2020
Quantra QPlus System
K201513 · QFR
Hemosonics, LLC
Hematology · 74d
Cleared Aug 21, 2020
DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A...
K201693 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 60d
Cleared Aug 21, 2020
Arthrex SwiveLock Anchor
K201749 · MAI
Arthrex, Inc.
Orthopedic · 56d
Cleared Aug 21, 2020
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES...
K202036 · MVN
Alcon Laboratories, Inc.
Ophthalmic · 29d
Cleared Aug 21, 2020
EzDent-i/ E2/ Prora View/ Smart M Viewer
K202116 · LLZ
Ewoosoft Co., Ltd.
Radiology · 22d
Cleared Aug 20, 2020
TidalPort-AP Implantable Apheresis Vascular Access Port
K192291 · PTD
Norfolk Medical Products, Inc.
General Hospital · 363d
Cleared Aug 20, 2020
Distinct® Early Detection Pregnancy Test
K193318 · LCX
ACON Laboratories, Inc.
Chemistry · 262d
Cleared Aug 20, 2020
Non-spermicidal Lubricated Male Latex Condom
K193578 · HIS
Global Protection Corp.
Obstetrics & Gynecology · 241d
Cleared Aug 20, 2020
Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use...
K200093 · LZA
Anhui Lntco Medical Products Co., Ltd.
General Hospital · 217d
Cleared Aug 20, 2020
Straumann TLX Implant System
K200586 · DZE
Institut Straumann AG
Dental · 167d
Cleared Aug 20, 2020
Electronic Blood Pressure Monitor
K200939 · DXN
Jiangsu Yuyue Medical Equipment&...
Cardiovascular · 134d
Cleared Aug 20, 2020
Hercules Suture Anchor System
K201636 · MBI
In2bones USA, LLC
Orthopedic · 65d
Cleared Aug 20, 2020
FUJIFILM Video Laparoscope
K202130 · GCJ
Fujifilm Corporation
General & Plastic Surgery · 20d
Cleared Aug 19, 2020
invisa-RED ELITE
K192275 · OLI
IR Technology, LLC
General & Plastic Surgery · 363d
Cleared Aug 19, 2020
VariLymph 12 pro
K193476 · JOW
Slk Medical GmbH
Cardiovascular · 247d
Cleared Aug 19, 2020
Omnichroma Flow
K193537 · EBF
Tokuyama Dental Corporation
Dental · 243d
Cleared Aug 19, 2020
Medline ReNewal Reprocessed Harmonic ACE+7 Shears
K193563 · NLQ
Surgical Instrument Service and...
General & Plastic Surgery · 240d