13 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
PROCARE
FDA UDI
DJO, LLC·00888912037921·LAMINECTOMY ARM CRADLE/TROUGH 5 PR/BX
AETOS Shoulder System
FDA UDI
Smith & Nephew, Inc.·00885556811863·HUMERAL PLANER LARGE
AETOS Shoulder System
FDA UDI
Smith & Nephew, Inc.·00885556811856·HUMERAL PLANER SMALL
AETOS Shoulder System
FDA UDI
Smith & Nephew, Inc.·00885556811849·HUMERAL PLANER MEDIUM
THERMO SCIENTIFIC CYTO-CAL COUNT TUBES
FDA 510(k)
FDA Class 2
·Hematology
OPERA, OPERA eco
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·February 19, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWP·April 9, 2015
COULTER® LH 500 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·March 5, 2013
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 8, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·August 8, 2014
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