14 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Digital Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
sentida 1
FDA UDI
WISSNER-BOSSERHOFF GmbH·04050621100401·Basic electric home bed
GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL
FDA 510(k)
FDA Class 2
·Orthopedic
EPOLY 32MM RLC LNR MROM SZ23
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·August 7, 2018
CER BIOLOXD OPTION HD 32MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·August 7, 2018
TPRLC 133 MP TYPE1 PPS HO 10.0
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·August 7, 2018
M/H SLD/APX HLE RNGLC SHL 50MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·August 7, 2018
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 21, 2014
HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC. MEDOS S.A.·Product code JXG·July 29, 2011
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 26, 2013
INSPIRE 7M HOLLOW FIBER OXYGENATOR, INSPIRE 7 DUAL HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·June 14, 2019
INSPIRE 7M HOLLOW FIBER OXYGENATOR, INSPIRE 7 DUAL HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·June 19, 2019
SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198
FDA Enforcement
Class II
·Ongoing·WISSNER-BOSSERHOFF GMBH·November 20, 2024