11 results · 20ms · Sources: EU EUDAMED, 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