10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
RII INFRARED EAR THERMOMETER, MODEL TH01BN
FDA 510(k)
FDA Class 2
·General Hospital
CAREO RETRACTABLE SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)
FDA 510(k)
FDA Class 2
·Radiology
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·March 29, 2013
AUTOPLEX W/VERTAPLEX HV
FDA Adverse Event
Injury
·STRYKER INSTRUMENTS PUERTO RICO·Product code LOD·April 19, 2011
ZMR HIP SYSTEM PROVISIONAL FEMORAL BODY REVISION
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code KWB·July 3, 2008
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
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024