12 results
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21ms
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Sources: EU EUDAMED, US FDA
TRILOGY SYSTEM WITH RAPIDARC
FDA 510(k)
FDA Class 2
·Radiology
ShurFit Interbody Device
FDA UDI
PRECISION SPINE, INC.·00840019910064·TPLIF Cage Peek 16mm x 29mm
ShurFit 2C Lumbar Interbody
FDA UDI
PRECISION SPINE, INC.·00840019929912·16mm x 29mm 2C TPLIF Cage PEEK
SURGI-VISION PROSTATE COIL
FDA 510(k)
FDA Class 2
·Radiology
FRONTIER ANTERIOR SCOLIOSIS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
WATCHPAT100
FDA Adverse Event
Injury
·ITAMAR MEDICAL LTD.·Product code MNR·November 12, 2007
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 27, 2021
FUJIFILM ENDOSCOPE MODELS EC-760R-V/M
FDA Adverse Event
Malfunction
·FUJIFILM CORPORATION·Product code FDF·March 25, 2024
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 23, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·April 29, 2011
KAPPA 700 DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·July 10, 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