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