17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODULAR PROXIMALLY FLUTED HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
BIO-MODULAR SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304213685·
GLOBAL
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295007326·GLOBAL ENDURON PE SHOULDER - GLENOID PEG SIZE 56XL
EXCELSIOR MICROCATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code DQY·April 13, 2010
SYNTHES STERNAL ZIPFIX SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189
FDA 510(k)
FDA Class 2
·Cardiovascular
EXCELSIOR MICROCATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code DQY·May 18, 2010
EXCELSIOR MICROCATHETER
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - CORK·Product code DQY·August 2, 2010
BIO MODULAR HUMERAL STEM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWT·February 19, 2018
BIOMODULAR SHOULDER HUMERAL HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·February 16, 2018
BIOMODULAR SHOULDER HUMERAL STEM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWT·February 16, 2018
BIOMODULAR SHOULDER PEGGED GLENOID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·February 16, 2018
PINNACLE 300 ACET CUP 54MM
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 15, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·June 3, 2011
NITE GUARD
FDA Adverse Event
Malfunction
·RANIR, LLC·Product code OBR·May 1, 2014
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025