14 results · 26ms · Sources: EU EUDAMED, US FDA

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MODEL MES-9000/EMG SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

MAGNIVISION

FDA UDI
FGX INTERNATIONAL INC.·00024021569049·

MAGNIVISION

FDA UDI
FGX INTERNATIONAL INC.·00024021569018·

MAGNIVISION

FDA UDI
FGX INTERNATIONAL INC.·00024021569025·

SONOSITE HAND-CARRIED ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

NITE GUARD

FDA Adverse Event
Malfunction ·RANIR LLC·Product code OBR·May 1, 2014

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 15, 2025

PRECISION®

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 20, 2013

LIGAMAX-5MM

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·March 10, 2011

SPRINT FIDELIS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 10, 2008

FEMORAL STEM 12/14 NECK TAPER

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·July 2, 2021

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