10 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN
FDA 510(k)
FDA Class 2
·Anesthesiology
LASERSKIN DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·July 3, 2018
CD HORIZON
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·March 15, 2017
2520274-2013-02134
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·April 29, 2013
LANDMARX ELEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 19, 2011
ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER- 33 MM
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC·Product code OCW·July 23, 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