9 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT
FDA 510(k)
FDA Class 1
·Microbiology
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0134150·Trial, TLIF, 27L OB STR 7Deg, 15mm
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNTHES ANKLE ARTHRODESIS PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
TRILOGY 200
FDA Adverse Event
Malfunction
·RESPIRONICS INC·Product code CBK·August 19, 2020
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·September 16, 2014
PLM A+ PLATINUM MODU
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA, LTD.·Product code FRN·April 12, 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