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

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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