9 results
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19ms
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Sources: EU EUDAMED, US FDA
NONCON ROBO PACHY F&A
FDA 510(k)
FDA Class 2
·Ophthalmic
SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
REMREST
FDA 510(k)
FDA Class 2
·Anesthesiology
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWA·April 17, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·June 18, 2008
BD INSYTE IV CATHETER
FDA Adverse Event
Other
·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·April 8, 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
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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018