8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OPTHERM EXTRA FINE TIP
FDA 510(k)
FDA Class 2
·Ophthalmic
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780399346·Integra® Jarit® Obwegeser Ramus Retractor, 8-3/...
ANTHRACIS REAL-TIME PCR ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
TRANS1 AXIAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 30, 2014
UNO UNOMETER 500 150CM BO H
FDA Adverse Event
Malfunction
·UNOMEDICAL LTD.·Product code FFG·June 11, 2015
GYNECARE MORCELLEX TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·September 10, 2010
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
FDA Enforcement
Class I
·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021