8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
FDA 510(k)
FDA Class 2
·Cardiovascular
MICROCRUISER PLUS INTRODUCER SET
FDA 510(k)
FDA Class 2
·Cardiovascular
SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SOFTCLIX ® LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·April 16, 2013
DEEP BRAIN STIMULATION LEAD
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·March 30, 2011
PERMANENT CAUTERY HOOK INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code GEI·June 13, 2008
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