13 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOTEQUE A.V. FISTULA NEEDLE SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
artegral life
FDA UDI
Merz Dental GmbH·D7091993118·anteriors; shade A3.5; mould UCL
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198116·AK3 PS Insert Trial Size 1, 18mm
Bipolar forceps
FDA UDI
SOPRO-COMEG GmbH·04059082014807·
BRAINLAB KNEE ARTHROSCOPY
FDA 510(k)
FDA Class 2
·Neurology
TGS Guidewire and updated Scopis Software
FDA 510(k)
FDA Class 2
·Neurology
MARDIS SOFT HYDRO URETERAL STENT WITH GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION-SPENCER·Product code FGE·March 3, 2009
MARDIS SOFT HYDRO URETERAL STENT WITH GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION-SPENCER·Product code FGE·March 5, 2009
EXPRESS VASCULAR SD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code FGE·March 7, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·February 16, 2011
BRAVA
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code NIK·August 8, 2014
CENTURION SURGICAL PROCEDURE PAK
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LLC - HOUSTON·Product code LRO·April 5, 2022
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026