8 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO N/T PROTEIN CONTROL SL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050
FDA 510(k)
FDA Class 2
·Anesthesiology
GRAFTYS HBS (510K NUMBER: K082498)
FDA Adverse Event
Injury
·GRAFTYS·Product code MQV·July 11, 2013
CRANIAL PERFORATOR, 14-11 MM
FDA Adverse Event
Injury
·THE ANSPACH EFFORT, INC.·Product code HBC·April 25, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 10, 2011
HIRES 90K
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·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