15 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
RETROGRADE KNIFE
FDA 510(k)
FDA Class 1
·Orthopedic
DSQ Alert Candida auris Probe Mix ASR
FDA UDI
Elitechgroup Mdx LLC·03661540952548·DSQ Alert™ Candida auris Probe Mix ASR is an an...
Arthrex®
FDA UDI
ARTHREX, INC.·00888867042520·3 HOLE DBL COMP PLATE, 30MM
IMPOAID
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
pjur WOMAN Nude pjur med SENSITIVE glide
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OXF TWIN-PEG CMNTD FEM MD PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·January 22, 2020
OXF UNI TIB TRAY SZ D LM PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·January 22, 2020
INTERSTIM NEUROSTIMULATOR, UNKNOWN
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·May 8, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 22, 2012
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·August 4, 2010
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·July 30, 2015
OXF ANAT BRG LT MD SIZE 5 PMA
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code NRA·January 22, 2020
OXF ANAT BRG LT MD SIZE 5 PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·March 30, 2020
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022