7 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT
FDA 510(k)
FDA Class 2
·General Hospital
LOWMAN BONE FORCEP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BLUGOO HD
FDA 510(k)
FDA Class 2
·Dental
MALLINCKRODT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code BTS·April 14, 2014
VITALITY
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 15, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 12, 2012
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015