16 results
·
23ms
·
Sources: EU EUDAMED, US FDA
FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST
FDA 510(k)
FDA Class 2
·Immunology
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033481745·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033481721·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033481738·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033481752·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132130·Trial, TLIF, 27L OB CRV 7Deg, 13mm
MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024
FDA 510(k)
FDA Class 2
·Cardiovascular
REMSTAR PLUS CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
M-SERIES DC POWER SUPPLY
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·May 25, 2012
SYNERGY
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 26, 2022
REMSTAR AUTO M SERIES
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·April 14, 2024
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·March 20, 2013
TALENT THROACIC STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·March 8, 2011
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·March 14, 2008
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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014