10 results
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18ms
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Sources: EU EUDAMED, US FDA
AUTO LUBE SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
3M™ ESPE™
FDA UDI
3M COMPANY·30605861031616·3M™ ESPE™ Gold Anodized Crown Refills, First Bi...
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665586865·MIS Cannulated Screw M, Ø10.5 x 35mm, Ø5.5mm Rod
PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GSN-132, F/G, STERILE, COVIDIEN
FDA Adverse Event
Malfunction
·RANFAC CORP.·Product code KNW·April 18, 2014
PELVISOFT ACELLULAR COLLAGEN BIOMESH
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTM·January 30, 2013
NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·December 21, 2010
Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures. Models: 5430-30151, 5430-30152, and 5430-30154
FDA Enforcement
Class II
·Ongoing·Mirion Technologies (Capintec), Inc.·February 21, 2024
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020