9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM
FDA 510(k)
FDA Class 2
·Orthopedic
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120307241·Diamond, flame non-cutting tip, extra fine grit...
MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B
FDA 510(k)
FDA Class 2
·Cardiovascular
YALE NH TT VISION SYS GBS
FDA Adverse Event
Other
·GISH BIOMEDICAL, INC.·Product code OEZ·December 3, 2010
DUAL COOLER/HEATER
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·March 27, 2013
5 FR DL POWERPICC UPFT WITH MI AND TLS
FDA Adverse Event
Injury
·C. R. BARD INC. (BASD)·Product code LJS·March 18, 2011
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·April 17, 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