9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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L-TENS
FDA 510(k)
FDA Class 2
·Neurology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704265378·
GREAT TOE IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·April 8, 2013
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·April 6, 2011
C-PORT XA DISTAL ANASTOMOSIS SYSTEM
FDA Adverse Event
Injury
·CARDICA, INC.·Product code FZP·May 12, 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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018