10 results · 33ms · Sources: EU EUDAMED, US FDA

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EZ-MIO, EZ-IO DISTAL TIBIA

FDA 510(k)
FDA Class 2 ·General Hospital

HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB

FDA 510(k)
FDA Class 2 ·Cardiovascular

ACCUSONIC A-SCAN MODEL, 24-4000

FDA 510(k)
FDA Class 2 ·Radiology

AMI

FDA Adverse Event
Other ·AIRWAY MANAGEMENT INC.·Product code LRK·July 10, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 17, 2013

ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORP.·Product code LZG·March 16, 2011

WALLSTENT ENTERAL ENDOPROSTHESIS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC IRELAND, LTD.·Product code MQR·June 19, 2008

AXON ECLIPSE CONTROLLER

FDA Adverse Event
Injury ·MEDTRONIC XOMED, INC·Product code GWF·October 4, 2013

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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015