9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
DXS DIGITAL X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 17, 2013
AXIEM PORTABLE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·March 22, 2011
ASR ACETABULAR IMPLANT 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWB·June 18, 2008
ZIMMER M/L TAPER FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER INC·Product code LZO·February 17, 2016
KINECTIV MODULAR NECK
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWA·May 26, 2016
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