9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRIDE UNICONDYLAR KNEE
FDA 510(k)
FDA Class 2
·Orthopedic
ArgenZ ST 98x14 ML D4
FDA UDI
ARGEN CORPORATION, THE·D818123380·Dental porcelain/ceramic restoration kit
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 8, 2024
T-WAVE ALTERMANS (TWA) ALGORITHM OPTION
FDA 510(k)
FDA Class 2
·Cardiovascular
PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
PRODIGY SR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·June 14, 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