45 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN
FDA 510(k)
FDA Class 1
·Dental
StruXure
FDA UDI
Nuvasive, Inc.·00887517408877·StruXure Template, Staple Insert
Preat
FDA UDI
Preat Corporation·00842092170458·ASC Zimmer TSV 3.5mm X 9mm Non-Engaging Titaniu...
LIFEPAK CR Plus and LIFEPAK Express defibrillators
FDA UDI
PHYSIO-CONTROL, INC.·00883873820384·DEVICE,LPCR,SEMI,BREATH,EN
LIFEPAK® CR Plus and LIFEPAK Express defibrillators
FDA UDI
PHYSIO-CONTROL, INC.·00885074740157·DEVICE,LPCR,SEMI,BREATH,EN
ESU Shroud
FDA UDI
I.C. MEDICAL, INC.·00817688021117·
Matrix Wearable
FDA UDI
GLOBAL INSTRUMENTATION, LLC·00815187020457·M5 3-Lead Patient Cable AHA
FlowLogic Agile
FDA UDI
SONENDO, INC.·00810209420338·FlowLogic Agile Shaping File 35/.04, 31mm
SJM TAILOR ANNULOPLASTY RING, MODEL TARN
FDA 510(k)
FDA Class 2
·Cardiovascular
MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDERED
FDA 510(k)
FDA Class 1
·General Hospital
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code MKJ·January 16, 2025
CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 23, 2024
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·July 18, 2025
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·February 14, 2013
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·February 18, 2011
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code LWR·February 18, 2008
CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·December 18, 2025
24MM BASEPLATE, 20° FULL AUG, +2 LAT, ST
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code PHX·August 13, 2025
5.5X24MM PERIPHERAL SCREW, LOCKING
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code PHX·August 13, 2025
MODULAR POST, 30MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code PHX·August 13, 2025