15 results
·
18ms
·
Sources: EU EUDAMED, US FDA
FRUCTOSAMINE TEST (ROCHE)
FDA 510(k)
FDA Class 2
·Hematology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994617903·LID 1854010 HOOK CADDY LID 1
DD cubeX² ML
FDA UDI
Dental Direkt GmbH·EDDIG8540101·High translucent zirconia for the manufacture o...
LOCATOR®
FDA UDI
Zest Anchors, LLC·00840481101434·LOCATOR® EXTENDED RANGE MALE PROCESSING PACKAGE...
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690111771·Modular Tibia Augment Size 1 x 4mm
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981125325·4.0mm Variable Screw, Self Tapping, 10mm
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690131021·High Performance Revision Tibia Augment, Size 1...
DERMATOPHYTE TEST MEDIUM
FDA 510(k)
FDA Class 1
·Microbiology
ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface
FDA 510(k)
FDA Class 2
·Radiology
POWER LOAD
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·October 31, 2012
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·January 29, 2014
AUTO ENDO APPLIER 5 M/L
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code GDO·September 2, 2010
Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement.
FDA Enforcement
Class II
·Terminated·Omni Life Science·September 19, 2012
Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement.
FDA Recall
Terminated
·Omni Life Science·Product code JWH·August 9, 2012
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015