11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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