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

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TAP III ANTI-SNORING DEVICE

FDA 510(k)
FDA Class 2 ·Dental

AMI

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

MAGELLAN VENTILATOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE

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

BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 5, 2022

CORONAL ROD BENDER-RIGHT FOR 5.5MM RODS

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HXW·April 17, 2013

ANIMAS INSULIN INFUSION PUMP

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

WALLFLEX ENTERAL COLONIC STENT

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

EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

FDA Adverse Event
Death ·AV-TEMECULA-CT·Product code NTE·March 4, 2011

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