18 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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ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
RESTORE
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 3, 2012
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033514030·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033514023·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033514009·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033513996·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033514016·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033514047·
Phonak
FDA UDI
Phonak AG·07613275085899·Phonak Naída Q90-SP (blue transparent)
HARDYDISK RIFAMPIN, 5MCG
FDA 510(k)
FDA Class 2
·Microbiology
LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
FDA 510(k)
FDA Class 2
·Microbiology
RESTORE
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 10, 2013
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·March 20, 2013
ISYMM ASPHERIC INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·HOYA SURGICAL OPTICS INC.·Product code HQL·February 3, 2011
GEM III VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·March 10, 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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·November 2, 2016