18 results · 22ms · Sources: EU EUDAMED, US FDA

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FDA 510(k)
FDA Class 2 ·Clinical Toxicology

CTS-415

FDA 510(k)
FDA Class 2 ·Radiology

ALBUMIN

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

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

ACCU-CHEK ® ULTRAFLEX INFUSION SET

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FPA·February 18, 2014

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

TELIGEN

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 9, 2013

ON-Q PAINBUSTER SOAKER

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

ENDOTAK RELIANCE G

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

25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·March 1, 2016

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

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

Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024