22 results · 21ms · Sources: EU EUDAMED, US FDA

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DISCOVERY FACET SCREW FIXATION SYSTEM

FDA 510(k)
FDA Unclassified ·Unknown

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033440940·

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033440957·

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033440933·

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033440971·

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033440964·

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033440988·

NEUROMAP WITH NEURO 100

FDA 510(k)
FDA Class 2 ·Neurology

BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS

FDA 510(k)
FDA Class 2 ·Radiology

ACTIVA

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code MHY·November 19, 2011

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·May 29, 2015

BILATERAL DOUBLE BALLOON SET

FDA Adverse Event
Malfunction ·PAJUNK GMBH MEDIZINTECHNOLOGIE·Product code KOG·December 7, 2006

SOLETRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·August 30, 2013

ACTIVA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 13, 2013

PROGRAMMING SOFTWARE

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·March 20, 2013

SIEMENS BRAND NAME

FDA Adverse Event
Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code IYE·March 2, 2011

COOL-TIP RF SYS 100V ENG

FDA Adverse Event
Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·March 12, 2008

ACTIVA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·August 6, 2015

ACTIVA

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·August 6, 2015

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