17 results · 23ms · Sources: EU EUDAMED, 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