120 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·AFP RIA KIT
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·AFP RIA KIT
GLUCOCARD® Vital™ BLOOD GLUCOSE METER
FDA UDI
ARKRAY USA, INC.·00015482760014·Portable Blood Glucose Meter
Philips IntelliSite Pathology Solution
FDA UDI
Philips Medical Systems Nederland B.V.·00884838092105·Whole Slide Imaging System. The device is an au...
Philips IntelliSite Pathology Solution
FDA UDI
Philips Medical Systems Nederland B.V.·00884838085640·Whole Slide Imaging System. The device is an au...
Washbon
FDA UDI
ORMCO CORPORATION·00889989042986·LOWER LEFT SECOND MOLAR WASHBON BAND SIZE 1
RIBFIX BLU SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036184391·
RIBFIX BLU SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036275280·
Automated Perimeter
FDA UDI
OPTOPOL TECHNOLOGY SP Z O O·05903293141120·The PTS 920 automated perimeter is a diagnostic...
AMIGO ESCORT 7.5, MODEL 760001 PHS
FDA 510(k)
FDA Class 2
·Physical Medicine
ARCH SUPPORT (ARCH AID)
FDA 510(k)TA 60-3.5 SINGLE USE STAPLER
FDA Adverse Event
Injury
·PONCE - USS·Product code GAG·February 28, 2008
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 14, 2015
Stent, Carotid
FDA Pre-Market Approval
FDA Class 3
·PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·OBALON BALLOON SYSTEM
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
KENSTONE METAL·Product code ITJ·September 26, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 18, 2013
SYNCHRON UNICEL DXC 800 PRO CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·July 16, 2010
Stent, Carotid
FDA Pre-Market Approval
FDA Class 3
·PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM
Stent, Carotid
FDA Pre-Market Approval
FDA Class 3
·Protégé GPS Self-Expanding Peripheral Stent System