20 results · 23ms · Sources: EU EUDAMED, US FDA

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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