9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
FDA 510(k)
FDA Class 2
·Medical Genetics
EarQ
FDA UDI
Oticon A/S·05707131343123·G20, MINIRITE 312 2.4G C090 EARQ
DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)
FDA 510(k)
FDA Class 2
·Radiology
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTL, LTD.·Product code KWA·October 3, 2008
OPEN SPINE CLAMP DRIVER
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 21, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 27, 2013
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·January 22, 2025
DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·July 10, 2019