24 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT
FDA 510(k)
FDA Class 2
·Dental
Natus
FDA UDI
XLTEK·00382830016476·Natus Quantum Patient Event Button 30ft
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450641118·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033540893·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033540886·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033540879·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033540862·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033540848·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033540855·
MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01
FDA 510(k)
FDA Class 1
·Microbiology
PANAG
FDA 510(k)
FDA Class 2
·Neurology
SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAK·November 18, 2019
PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·November 18, 2019
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 20, 2013
TENDRIL ST
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011
SPRINT FIDELIS
FDA Adverse Event
Malfunction
·MEDTRONIC INC.·Product code LWS·February 15, 2008
ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·November 27, 2019
ETS*ENDO ARTICU LIN CUTTER WHI
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 25, 2019
PENUMBRA SMART COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·August 14, 2017
ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 7, 2016