8 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PCR ELEVA 1.2
FDA 510(k)
FDA Class 2
·Radiology
SPARC SLING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ASYRA
FDA 510(k)
FDA Class 2
·Neurology
EDWARDS TRANSCATHETER INTRODUCER SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·December 11, 2019
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 26, 2013
OPTICROSS?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code OBJ·September 16, 2014
LINK(R) SPII COCR HEAD
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JDI·April 19, 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