10 results · 17ms · Sources: EU EUDAMED, US FDA

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MULTI DOPPLEX, MD-1

FDA 510(k)
FDA Class 2 ·Radiology

N/A

FDA UDI
Smith & Nephew, Inc.·00885556601198·MTO DISSECTOR BLUNT STRAIGHT ECTRA II

DATEX-OHMEDA CS/3 TELEMETRY SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE

FDA 510(k)
FDA Class 2 ·General Hospital

SNAP-RING FOR 52MM OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWB·December 4, 2007

UNKNOWN EXACTA EDMS DEVICE

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROSURGERY·Product code GWM·June 27, 2014

TOTALCARE

FDA Adverse Event
Malfunction ·HILL-ROM INC.·Product code FNL·November 9, 2010

HORIZON TI CLIPS MEDIUM

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code FZP·December 12, 2012

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. NF1505, IV ADMIN SET W/2 H.F. STOPCOCKS; Catalog Number: 490088. 2. IV ADMIN SET W/2 SAFELINE & HF STOPCOCK; Catalog Number: 490107.

FDA Enforcement
Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. NF1505, IV ADMIN SET W/2 H.F. STOPCOCKS; Catalog Number: 490088. 2. IV ADMIN SET W/2 SAFELINE & HF STOPCOCK; Catalog Number: 490107.

FDA Recall
Open, Classified ·B Braun Medical Inc·Product code FPA·October 29, 2025