9 results
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18ms
·
Sources: EU EUDAMED, US FDA
BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSI
FDA 510(k)
FDA Class 2
·Radiology
OXYGUARD
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
SOFTWARE PROGRAM USED W/PRISM PRODUCTS
FDA 510(k)
FDA Class 2
·Cardiovascular
PORTEX® BIVONA® AIRE-CUF® NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·March 28, 2017
PORTEX®BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.,·Product code JOH·June 28, 2016
130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAI
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·February 1, 2013
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·January 3, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 18, 2014
Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 37351-30-N, 37351-32-N, 37351-34-N, 37351-36-N, 37351-38-N, 37351-40-N, 37351-42-N, 37351-44-N, 37351-46-N, 37351-48-N, 37351-50-N, 37351-55-N, 37351-60-N, 37351-65-N, 37351-70-N, 37351-75-N, 37351-80-N, 37351-85-N. 2. Humeral Plate, Distal; Article Numbers: 21241-5, 21241-7, 21242-7, 21243-10, 21244-9.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026