9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COBAS READY TOTAL PROTEIN REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PALS
FDA UDI
AXELGAARD MANUFACTURING CO., LTD.·00856817005512·
LIGATURE NEEDLES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV.
FDA 510(k)
FDA Class 2
·Cardiovascular
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·June 13, 2014
IDENTITY XL DR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2010
LRG TAP PRI MOD NCK 0DEG 38MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code JDI·December 28, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019