7 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACE RECONSTRUCTIVE PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
CATARRHALIS TEST STRIP
FDA 510(k)
FDA Class 1
·Microbiology
NOVA LITE(TM) ANA MK
FDA 510(k)
FDA Class 2
·Immunology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·January 9, 2013
MINICAP EXTEND LIFE PD TRANSFER SET - JAPAN
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·November 23, 2010
ADVANCE(R) II COCR TIBIAL BASE
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code HRY·July 1, 2014
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