10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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THE TAPER-FIT TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NATURAL EXTENSIONS
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975025210·Natural Extensions COATS™ Oatmeal Small Nitrile...
DYNESYS TOP-LOADING SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ActiPatch
FDA 510(k)
FDA Class 2
·Physical Medicine
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·February 22, 2019
BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code MEG·April 16, 2018
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 7, 2013
SIGMA 300 DR
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO·Product code NVZ·August 8, 2014
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code MMI·February 15, 2011
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021