13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRECISION 500D R&F X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014609478·BERCHTOLD 2" STANDARD
CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01
FDA 510(k)
FDA Class 2
·Cardiovascular
EBI XFIX DFS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·March 17, 2016
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·April 10, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 14, 2011
ETS FLEX ARTICNG LNR CUTR 45MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDW·July 21, 2008
HOSP SS FLEXX METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·February 22, 2011
ARROW AU-00420-MAJO
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code DQY·January 2, 2019
HOSP SS FLEXX METER W/O LASER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 17, 2011
HOSP SS FLEXX METER
FDA Adverse Event
Death
·LIFESCAN INC.·Product code NBW·April 1, 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