20 results
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36ms
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Sources: EU EUDAMED, US FDA
EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526189782·***DISC***LEVAMED ACTIVE ANKLE SUP BL
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450509708·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033513439·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033513415·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033513408·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033513446·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033513460·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033513453·
BIOSLING - BIOABSORBABLE POLYMER SLING & SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L
FDA 510(k)
FDA Class 2
·General Hospital
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·March 20, 2013
ISYMM ASPHERIC INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·HOYA SURGICAL OPTICS INC.·Product code HQL·February 3, 2011
SPRINT QUATTRO
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 10, 2008
HARMONIC ACE 5MM SHEAR
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·February 4, 2020
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
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