13 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OLYMPUS IGM REAGENT
FDA 510(k)
FDA Class 2
·Immunology
HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STIMATE N601 TENS
FDA 510(k)
FDA Class 2
·Neurology
WAVEWRITER ALPHA 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 10, 2024
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
MICRO OSCILLATING SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·April 23, 2013
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·May 1, 2011
ATLAS II PLUS HF CRT-D
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2008
UNK
FDA Adverse Event
Injury
·VISTAKON·Product code LPL·October 11, 2010
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