23 results · 26ms · Sources: EU EUDAMED, US FDA

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OMNILUX RED

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Endo GIA

FDA UDI
Covidien LP·10884523003000·Universal Loading Unit

ALGINATE IMPRESSION MATERIAL

FDA 510(k)
FDA Class 2 ·Dental

VIP- VARIABLE INTENSITY POLYMERIZER

FDA 510(k)
FDA Class 2 ·Dental

C21617 DE LIFE SYSTEMS $PHISIO

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·October 24, 2013

BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·June 16, 2023

FLOGARD

FDA Adverse Event
Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·April 2, 2013

MINILOK QUICKANCHOR PLUS W/#2/0 SUTURE

FDA Adverse Event
Injury ·DEPUY MITEK·Product code MBI·March 18, 2011

KIMBERLY-CLARK* TRACH CARE PRODUCTS

FDA Adverse Event
Malfunction ·AVENT S.A. DE C.V.·Product code BTR·April 17, 2008

CP82200 I MIRANDOLA

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·April 6, 2012

YALE NH TT VISION SYS GBS

FDA Adverse Event
Other ·GISH BIOMEDICAL, INC.·Product code OEZ·December 3, 2010

CP85341 FR PARIS

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011

EMORY/CL/KNNSTN ATLANTA GA1

FDA Adverse Event
Other ·SORIN GROUP USA·Product code DWF·August 19, 2010

DUKE UNIV DURHAM NC 1

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DWF·July 15, 2011

COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

FDA Adverse Event
Death ·SORIN GROUP ITALIA SRL·Product code KFM·November 23, 2016

COBE CARDIOVASCULAR REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

FDA Adverse Event
SORIN GROUP ITALIA·Product code KFM·February 29, 2016

REVOLUTION CENTRIFUGAL BLOOD PUMP

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code KFM·July 20, 2018

COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

FDA Adverse Event
Death ·SORIN GROUP ITALIA SRL·Product code KFM·October 6, 2016

COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

FDA Adverse Event
SORIN GROUP ITALIA SRL·Product code KFM·October 5, 2016

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