14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CUFF,DS,NEO,CM1500A,3.1-5.7,20 (1ea=20p)
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904005232·
THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
EMIT 2000 VANCOMYCIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PLATE BD CHROMAGAR O-157 20 EA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JSI·August 10, 2021
PLATE BD CHROMAGAR O-157 20 EA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JSI·August 10, 2021
COMPR 12MM IM HMRL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBF·April 1, 2019
VERTEBRAL SPACER-PR 10MMX24MM 7MM HEIGHT
FDA Adverse Event
Malfunction
·SYNTHES ELMIRA·Product code MQP·April 22, 2013
FLOSEAL HEMOSTATIC MATRIX
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - HAYWARD·Product code LMF·April 27, 2011
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·July 2, 2008
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
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