10 results
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30ms
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Sources: EU EUDAMED, US FDA
STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101
FDA 510(k)
FDA Class 2
·General Hospital
ACTICOAT COMPOSITE DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
BIS/EEG MODULE
FDA 510(k)
FDA Class 2
·Neurology
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014
QUATTRODE LEAD WIDE SPACED, 30 CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 8, 2015
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 13, 2021
UNKNOWN DEPUY PINNACLE METAL LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWY·April 23, 2013
RESERVOIR 3CC
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·April 22, 2011
CAPSURE VDD
FDA Adverse Event
Injury
·MEDTRONIC, B.V.·Product code DTB·July 10, 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