12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSTEOPORE TCP
FDA 510(k)
FDA Class 2
·Orthopedic
MODEL 4815 ADAPTER
FDA 510(k)
FDA Class 2
·Cardiovascular
CARBON POST
FDA 510(k)
FDA Class 1
·Dental
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 17, 2013
HICKMAN 10 FR TRIPLE-LUMEN CV CATHETER, PEEL-APART INTRODUCE
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (BASD)·Product code LJS·March 18, 2011
ARTICUL/EZE BALL 28 +5 BR
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·June 17, 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
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022