10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SEEDNET, MODEL EP6T5, EP5E5
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 27, 2013
RESERVOIR 3CC
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FRN·March 16, 2011
SYNVISC (HYLAN G-F 20) INJECTION
FDA Adverse Event
Other
·GENZYME CORPORATION (RIDGEFIELD)·Product code MOZ·June 18, 2008
PIPELINE
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·March 19, 2025
PIPELINE
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·March 20, 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