9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FORCETRIAD ELECTROSURGICAL GENERATOR; LIGASURE INSTRUMENTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306802119·Ochsner Hemostatic Forceps, Curved, 1x2 Teeth, ...
EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026
FDA 510(k)
FDA Class 2
·Cardiovascular
METRISCAN BONE DENSITY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 13, 2025
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 15, 2013
COAGUCHEK S SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JPA·July 3, 2008
UNKNOWN DEPUY SZ 3 10MM CVD TIBIAL INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·April 25, 2011
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024