13 results
·
25ms
·
Sources: EU EUDAMED, US FDA
HTSH RIA HUMAN THYROID HORMONE RIA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NA
FDA UDI
Zimmer, Inc.·00889024132313·
Minimally Invasive Solutions™ Technology
FDA UDI
Zimmer, Inc.·00887868550713·
Minimally Invasive Solutions™ Technology
FDA UDI
Zimmer, Inc.·00887868550706·
NA
FDA UDI
Zimmer, Inc.·00889024132306·
ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13
FDA 510(k)
FDA Class 2
·Dental
OmniCap
FDA 510(k)
FDA Class 2
·Anesthesiology
SMALL NPWT FOAM FILLER KIT
FDA Adverse Event
Malfunction
·SMITH & NEPHEW WOUND MANAGEMENT·Product code BTA·April 24, 2014
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·October 3, 2012
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 15, 2008
Zimmer Minimally Invasive Solutions Technology, Offset Rasp Handle, Left, 45 degrees, non-sterile; REF/Catalog #: 7712-35-01, Zimmer U.K. Ltd., SN3, 4FP, UK
FDA Recall
Terminated
·Zimmer Inc.·Product code LXH·June 28, 2007
Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; REF 7712-35-02, Zimmer U.K. Ltd., SN3, 4FP, UK
FDA Recall
Terminated
·Zimmer Inc.·Product code LXH·June 28, 2007
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021