12 results
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19ms
·
Sources: EU EUDAMED, US FDA
LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450497852·
MIMIX BONE REPLACEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
3.75MM AND 5.0MM SPLINE TWIST IMPLANT
FDA 510(k)
FDA Class 2
·Dental
VELA VENTILATOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code CBK·July 21, 2015
ROUND FILTER POLYPROVPYLENE
FDA Adverse Event
Malfunction
·SPS MEDICAL SUPPLY CORP·Product code FRG·June 25, 2013
VELA VENTILATOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code CBK·February 19, 2015
2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 28MM
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HRS·May 6, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 16, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS INNOVATION CENTER-SILICON VALLEY·Product code GEX·April 6, 2011
IMPL TWIST MTX 3.75 MM 10 MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 17, 2024
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