Search FDA 510(k) Database

7,005 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
18841–18864 of 174,061
Cleared Mar 13, 2020
Disposable SpO2 Sensor
K200069 · DQA
Shenzhen Changke Connect Electronics...
Anesthesiology · 60d
Cleared Mar 13, 2020
3DMetal Diaphyseal Femoral Cones
K200075 · JWH
Medacta International S.A.
Orthopedic · 59d
Cleared Mar 13, 2020
CS 9600
K200183 · OAS
Trophy
Radiology · 49d
Cleared Mar 13, 2020
Stat Profile Prime Plus Analyzer System
K200349 · CGA
Nova Biomedical Corporation
Chemistry · 30d
Cleared Mar 13, 2020
Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula,...
K200358 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 29d
Cleared Mar 13, 2020
LEGION Inserts with JRNY Lock
K200407 · JWH
Smith & Nephew, Inc.
Orthopedic · 23d
Cleared Mar 12, 2020
RefleXion Medical Radiotherapy System
K190978 · IYE
Reflexion Medical, Inc.
Radiology · 332d
Cleared Mar 12, 2020
Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
K191638 · DIO
Medtest DX
Toxicology · 267d
Cleared Mar 12, 2020
SpaceStation MRI
K191910 · MRZ
B. Braun Melsugen AG
General Hospital · 239d
Cleared Mar 12, 2020
NEOLab Clear Aligners
K192338 · NXC
New England Ortho Lab, Inc.
Dental · 197d
Cleared Mar 12, 2020
SonoVision Ultrasound Imaging System
K192388 · IYN
Tissue Differentiation Intelligence, LLC
Radiology · 191d
Cleared Mar 12, 2020
elysion-pro
K193367 · GEX
High Technology Products S.L.U
General & Plastic Surgery · 99d
Cleared Mar 12, 2020
BioNourish Lubricant
K193448 · NUC
Good Clean Love, Inc.
Obstetrics & Gynecology · 90d
Cleared Mar 12, 2020
Tritium Sternal Cable Plate System
K193468 · JDQ
Pioneer Surgical Technology, Inc....
Orthopedic · 87d
Cleared Mar 12, 2020
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K193538 · JWY
Thermo Fisher Scientific
Microbiology · 83d
Cleared Mar 12, 2020
AMT Suture Delivery System
K193612 · KGC
Applied Medical Technology, Inc.
Gastroenterology & Urology · 77d
Cleared Mar 12, 2020
Health Line CT Midline Catheter
K200263 · FOZ
Health Line International Corporation
General Hospital · 38d
Cleared Mar 12, 2020
Arthrex FiberTak Suture Anchor
K200341 · MBI
Arthrex, Inc.
Orthopedic · 30d
Cleared Mar 11, 2020
AC5 Topical Gel
K190129 · FRO
Arch Therapeutics, Inc.
General & Plastic Surgery · 408d
Cleared Mar 11, 2020
Fixone Biocomposite Anchor
K192484 · MAI
Aju Pharm Co., Ltd.
Orthopedic · 183d
Cleared Mar 11, 2020
Apollo Suture Anchor System
K192810 · MBI
Valeris Medical
Orthopedic · 162d
Cleared Mar 11, 2020
MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit
K192924 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 147d
Cleared Mar 11, 2020
KLS Martin Individual Patient Solutions (IPS) Planning System
K192979 · PBF
KLS-Martin L.P.
Orthopedic · 139d
Cleared Mar 11, 2020
Vista Dyes
K193447 · LFC
Inter-Med/Vista Dental Products
Dental · 89d