8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE
FDA 510(k)
FDA Class 2
·Cardiovascular
TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107
FDA 510(k)
FDA Class 2
·Cardiovascular
ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INSIGNIA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 9, 2013
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·February 25, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 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
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018