10 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DS-A BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PB560 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·August 22, 2011
BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PB560 VENTILATOR X1
FDA Adverse Event
Malfunction
·NELLCOR PURITAN BENNETT·Product code CBK·April 20, 2011
TORNIER
FDA Adverse Event
Malfunction
·TORNIER INC.·Product code HWC·September 3, 2010
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·May 4, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·April 29, 2013
CALAXO - UNKNOWN
FDA Adverse Event
Other
·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code HWC·July 25, 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