81 results · 25ms · Sources: EU EUDAMED, US FDA

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PuRE PMMA Disc

FDA 510(k)
FDA Class 2 ·Dental

THERMAL MASSAGE BED, MODEL 2D-GX

FDA 510(k)
FDA Class 2 ·Physical Medicine

NEXGEN PROLONG ALL-POLY PATELLA

FDA 510(k)
FDA Class 2 ·Orthopedic

LAMITRODE S-8 LEAD KIT, 60CM LENGTH

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code LGW·August 26, 2025

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 15, 2014

URETEX SUP URETHRAL SUPPORT SYSTEM

FDA Adverse Event
Injury ·SOFRADIM PRODUCTION·Product code OTN·April 26, 2013

UNICEL DXC 600 SYNCHRON SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 24, 2011

Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

FUSION OMNI-TOME

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code KNS·June 29, 2021

FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code KNS·May 27, 2021

FUSION OMNI-TOME

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code KNS·June 1, 2021

FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code KNS·April 4, 2022

FUSION OMNI-TOME

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code KNS·May 28, 2021

FUSION OMNI-TOME

FDA Adverse Event
Injury ·COOK ENDOSCOPY·Product code KNS·July 19, 2021

FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·December 13, 2023

FUSION OMNI-TOME

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code KNS·January 11, 2021

FUSION OMNI-TOME

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code KNS·April 29, 2021

FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code KNS·May 20, 2021

FUSION OMNI-TOME

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code KNS·May 3, 2021

FUSION OMNI-TOME

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code KNS·May 28, 2021