22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AIDA WITH DICOM AND HL7 INTERFACE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PLASMA SPRAYED SHOULDER
FDA 510(k)
FDA Class 2
·Orthopedic
HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREAT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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
POLYFLUX 17L
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER·Product code KDI·January 14, 2020
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 9, 2013
MICRO SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·March 15, 2011
ENDOTAK RELIANCE G
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS·Product code LWS·May 8, 2008
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 10, 2021
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 28, 2022
PROFILE 3D
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 30, 2021
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 22, 2021
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