9 results
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30ms
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Sources: EU EUDAMED, US FDA
UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDOLOOP LIGATURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GEA·December 28, 2018
ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 26, 2018
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code NIQ·November 19, 2008
JUVEDERM ULTRA PLUS XC 1 ML ROW
FDA Adverse Event
Injury
·ALLERGAN·Product code LMH·July 19, 2013
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023