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