20 results
·
23ms
·
Sources: EU EUDAMED, US FDA
CYTOGUARD(TM) CLOSED LUER CONNECTOR
FDA 510(k)
FDA Class 2
·General Hospital
7910 MASK
FDA UDI
HANS RUDOLPH, INC.·00874750009244·7910L 2WAY FACE MASK LG
Gibralt
FDA UDI
Choice Spine, LP·00840996169936·GIBRALT,CONNECTOR,H2H,C-CONNECT,26-36
IMPACTOR-POLY LINER-36MM
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OQG·February 15, 2017
BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
FDA 510(k)
FDA Class 2
·Cardiovascular
ZENITH PEDICLE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MAINFRAME 8253001 NIM RESPONSE 3.0
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETN·February 24, 2014
EMG TUBE 8229737 3PK NIM TRIVANTAGE 7MM
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code ETN·November 12, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013
UNKNOWN DEPUY SLEEVE
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code MRA·May 19, 2011
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code LFL·August 11, 2008
NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETN·July 19, 2016
NIM® 3.0 MAINFRAME
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code ETN·January 14, 2015
U BY KOTEX SLEEK
FDA Adverse Event
Malfunction
·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018
U BY KOTEX SLEEK
FDA Adverse Event
Malfunction
·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018
NIM® 3.0 MAINFRAME
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code ETN·August 15, 2016
NIM® PROBE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETN·March 23, 2018
NIM® PROBE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETN·May 11, 2015
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025