10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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YOUNG PROPHY SYSTEM, PS UNIT
FDA 510(k)
FDA Class 2
·Dental
PHLEBOPUMP, MODEL 1000
FDA 510(k)
FDA Class 2
·Cardiovascular
1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
IV SET AN125 W/O BP 200C
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·August 14, 2019
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 30, 2014
EYE STRETCHER CHAIR
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FMR·January 9, 2013
PFC SIGMA FEM STEM BOLT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·November 12, 2010
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 14, 2013
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 8, 2013
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