10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SKINTACT ECG ELECTRODE
FDA 510(k)
FDA Class 2
·Cardiovascular
Humeris Shoulder
FDA UDI
FX SOLUTIONS·03701037307113·TRIAL CENTERED SPACER Ø35 +3 mm 0°
DL800 Patient Cable
FDA UDI
BRAEMAR MANUFACTURING, LLC·B146DL830·
MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR
FDA 510(k)
FDA Class 2
·Orthopedic
N LATEX CYSTATIN C
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·March 27, 2013
NC QUANTUM APEX PTCA DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·March 18, 2011
8MM MCS TIP COVER ACCESSORY
FDA Adverse Event
Other
·INTUITIVE SURGICAL, INC.·Product code GEI·March 28, 2008
RADIESSE DERMAL FILLER
FDA Adverse Event
Other
·MERZ AESTHETICS, INC.·Product code LMH·August 16, 2012
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