15 results
·
30ms
·
Sources: EU EUDAMED, US FDA
RESPIRONICS
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, LLC·Product code MNS·June 8, 2021
BIPAP FOCUS
FDA 510(k)
FDA Class 2
·Anesthesiology
RESPIRONICS
FDA Adverse Event
Malfunction
·Product code MNT·May 19, 2021
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776310356·Stevens Tenot Scissors
WU'S 3-WHEELED NEO SCOOTER, WT-T3B
FDA 510(k)
FDA Class 2
·Physical Medicine
IMUBIND PLASMA PAI-1 ELISA,MODEL 822
FDA 510(k)
FDA Class 2
·Hematology
SYNCHRO GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP.·Product code DQX·October 16, 2009
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 27, 2008
PROTECTA XT DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·April 13, 2011
SYNCHRO GUIDEWIRE
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·August 2, 2010
SYNCHRO GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·May 27, 2010
SYNCHRO GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·April 15, 2010
SYNCHRO2-14 SUPPORT STRAIGHT 215CM
FDA Adverse Event
Malfunction
·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·December 14, 2023
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