30 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AGFA HEARTLAB CARDIOVASCULAR
FDA 510(k)
FDA Class 2
·Radiology
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·September 17, 2013
LATERALIZED AND AUGMENTED BASEPLATE
FDA UDI
FX SOLUTIONS·03701037316849·TA6V CEMENTLESS GLENOID BASEPLATE W/ SCREW LATE...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306830853·Scissors, Kelly Uterine, Straight, 17.75cm
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450141892·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450139844·
TLS 5.0
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B0301000502280·Rotating Distractor, QC, IBFD, 15mm
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENTEC CONTROLLER, ENTEC PATIENT CABLE, FOOTSWITCH, POWERCORD, PLASMA WAND
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RECLAIM DEEP BRAIN STIMULATION FOR OCD
FDA Adverse Event
Injury
·Product code OLM·April 9, 2013
NEUROPFORM3 MICRODELIVERY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORP.·Product code NJE·May 22, 2008
EASYTRAK 3
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·April 12, 2011
SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTN·November 20, 2020
CARDIOPLEGIA HEAT EXCHANGER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTN·April 29, 2020
VANGUARD
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTN·April 4, 2023
SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTN·December 15, 2023
BCD VANGUARD N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTN·January 15, 2024
CELLEX PHOTOPHERESIS SYSTEM
FDA Adverse Event
Malfunction
·MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED·Product code LNR·November 28, 2022
SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTN·March 22, 2019
NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTN·November 25, 2022