21 results
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40ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENFANTTM
FDA 510(k)
FDA Class 2
·Neurology
AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CRYOCYTE PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KSR·April 9, 2013
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 28, 2014
CONTAK RENEWAL 3 RF
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
ZILVER 635 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·May 25, 2011
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
TAPERLOC POROUS FEMORAL STEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·August 31, 2017
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
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
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