7 results
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19ms
·
Sources: EU EUDAMED, US FDA
CYBREX TM FPQ FLUORESCENE POLARIZATION
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DERMAGRIP POWDERFREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
EVERCROSS .035 OTW PTA DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·May 9, 2014
TRILOGY LONGEVITY POLY LINER
FDA Adverse Event
Malfunction
·ZIMMER·Product code LPH·October 19, 2012
MESH - COMPOSIX
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·August 11, 2010
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