18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ONLINE DAT BENZODIAZEPINES PLUS
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