11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MCI-Neuro Fixation System
FDA 510(k)
FDA Class 2
·Neurology
LEONE SPA
FDA UDI
LEONE SPA·08033707039372·SUPER EDGEWISE DB BRACKET 22 KIT
TLC Uni Knee Meniscal Insert
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215077440·
MAC-LINE CO2 NASAL CANNULA SAMPLE LINE
FDA 510(k)
FDA Class 2
·Anesthesiology
FUJINON COLONOSCOPES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GMK-SPHERE PATELLA RESURFACING SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 10, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·October 25, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 15, 2011
DIMENSION VISTA 500
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code NGS·July 9, 2013
Sheep Blood, Defibrinated - Catalog Number 212391, Unit 250 ml.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JSO·July 2, 2004
The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With its primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories. Each system includes a pumping module (hereafter called the infuser) and an assortment of disposable IV sets (hereafter called a set), and optional accessories. The Plum A+ host device contains a Connectivity Engine peripheral module that provides wired Ethernet and wireless 802.11 a/b/g local area networking capabilities. This allows the Hospira Mednet networked application software to download drug libraries to the infuser and enable the autoprogramming feature.
FDA Enforcement
Class II
·Terminated·Hospira Inc.·June 15, 2016