18 results · 29ms · Sources: EU EUDAMED, US FDA

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OMNILUX REVIVE AND BLUE

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

SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217

FDA 510(k)
FDA Class 2 ·Hematology

DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS

FDA 510(k)
FDA Class 2 ·Orthopedic

CP840442 DE LEIPZIG

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTZ·May 12, 2010

CP025369 DE LEIPZIG

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTZ·August 3, 2011

CP85315 IT MODENA

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·January 14, 2013

CP84050 FR LA REUNION

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·May 17, 2012

CP84042 DE LEIPZIG %

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DWE·April 20, 2011

D905 DIDECO EOS SINGLE HVR

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·September 25, 2013

PROGRASP FORCEPS INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·April 9, 2013

ON-Q PAINBUSTER

FDA Adverse Event
Malfunction ·I-FLOW CORP.·Product code MEB·February 25, 2011

VITALITY 2 DR EL

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

ALINITY I HAVAB IGM REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LOL·March 26, 2026

D905 EOS OXYGENATOR (PHISIO TREATED)

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTZ·July 13, 2018

D905 EOS PHISIO OXYGENATOR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTZ·August 8, 2017

SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

FDA Enforcement
Class II ·Terminated·Unomedical As·November 9, 2016

Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

FDA Enforcement
Class II ·Terminated·Unomedical As·July 1, 2015

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