198 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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THYRO TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Weisman Graves Medium
FDA UDI
MEDGYN PRODUCTS, INC.·M803030912·Weisman Graves Medium - Left Side Open 1 3/8" x...
ALARMVIEW WIRELESS DATA NETWORK SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PHOSPHORUS REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CONV PIN IV FAT CLVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 28, 2013
THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (DDC)
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·March 21, 2011
GE OEC 9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·April 17, 2008
BD¿ INSYTE AUTOGUARD CATHETERS
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 3, 2018
PRECISION SPECTRA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 4, 2022
OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
22 G X 1 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·September 21, 2017
BD PHOENIX¿ NMIC-311
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026
BD PHOENIX¿ NMIC-311
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 28, 2026
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 14, 2026
Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2.S_.EU 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
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 3, 2026
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·May 27, 2026
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 20, 2026