10 results · 19ms · Sources: EU EUDAMED, US FDA

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MAGNETOM ESPREE SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

Entuit Thrive

FDA UDI
XERIDIEM MEDICAL DEVICES, INC.·00827002356146·Entuit Gastrostomy BR Balloon Retention Feeding...

CYCLOSPORINE CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 19, 2025

INSIGNIA

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 8, 2013

SWEET PICOTIP RX

FDA Adverse Event
Injury ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

ENDOTAK RELIANCE

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NVY·April 6, 2011

TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.

FDA Enforcement
Class II ·Terminated·Synthes (USA) Products LLC·August 24, 2016

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