11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CIRRUS HD-OCT, MODEL 4000
FDA 510(k)
FDA Class 2
·Ophthalmic
EBI XFIX DFS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ORIA CLARIS
FDA 510(k)
FDA Class 2
·Orthopedic
PERFUSION PUMP
FDA Adverse Event
Malfunction
·COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON·Product code GEI·March 28, 2013
BLAKE DRAIN
FDA Adverse Event
Injury
·ETHICON, INC·Product code KOG·April 19, 2011
CARPENTIER-EDWARDS PARIMOUNT MAGNA AORTIC BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·June 19, 2008
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DQX·August 30, 2023
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·December 23, 2022
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 19, 2025
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015