9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EASYMATE BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Premier K-FILES
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6919053312·FILES PKG 6 31MM 45-80
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690129011·Revision Tibia Augment Peg Bolt Size 12mm
P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)
FDA 510(k)
FDA Class 2
·Orthopedic
CONTROL PLASMA P
FDA 510(k)
FDA Class 2
·Hematology
FLEXTEND II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 11, 2013
PERFIX PLUG
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·May 23, 2008
ALTRUA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 13, 2011
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