20 results · 24ms · Sources: EU EUDAMED, US FDA

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BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR

FDA 510(k)
FDA Class 2 ·Hematology

DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

INFINION CX

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 9, 2019

ALARIS PUMP MODULE ADMINISTRATION SET

FDA Adverse Event
Malfunction ·CAREFUSION CORP.·Product code FPA·March 13, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 28, 2011

VITALITY DR

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

ZILVER 635 BILIARY SELF-EXPANDING STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·May 25, 2011

PRODISC-L SUP-PL SIZ M 6°

FDA Adverse Event
Injury ·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code MJO·December 21, 2017

ZILVER 635 BILIARY SELF-EXPANDING STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD.·Product code FGE·April 11, 2011

ZILVER 635 BILIARY SELF-EXPANDING STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·September 5, 2012

ZILVER 635 SELF EXPANDING BILIARY STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·June 13, 2014

ZILVER 635 BILIARY SELF-EXPANDING STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·May 30, 2014

ZILVER 635 BILIARY SELF EXPANDING STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·February 13, 2012

ZILVER 635 SELF-EXPANDING BILIARY STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·July 2, 2014

ZILVER 635 SELF-EXPANDING BILIARY STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·July 16, 2014

ZILVER 635 BILIARY SELF-EXPANDING STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD.·Product code FGE·April 14, 2011

ZILVER 635 BILIARY SELF-EXPANDING STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·February 1, 2012

ZILVER 635 SELF-EXPANDING BILIARY STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·December 12, 2014

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012