21 results · 40ms · Sources: EU EUDAMED, 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