195 results
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38ms
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Sources: EU EUDAMED, US FDA
ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4
FDA 510(k)
FDA Class 2
·Dental
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code OEQ·August 19, 2024
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450146309·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450143148·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450140512·
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·October 23, 2024
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690122791·Modular Stem 25mm x 150mm
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690199519·Modular Knee Straight Reamer - 25mm
Orthex
FDA UDI
ORTHOPEDIATRICS CORP.·00841132180075·Ring, Half 255m
Orthex
FDA UDI
VILEX IN TENNESSEE, INC.·00841731123480·Orthex Half Ring 255mm
Orthex External Fixation System
FDA UDI
ORTHOPEDIATRICS CORP.·00840194408776·Orthex Half Ring 255mm, Green
Orthex External Fixation System
FDA UDI
ORTHOPEDIATRICS CORP.·00840194408769·Orthex Half Ring 255mm, Gold
Orthex External Fixation System
FDA UDI
ORTHOPEDIATRICS CORP.·00840194408721·Orthex Half Ring 255mm, Clear
Orthex External Fixation System
FDA UDI
ORTHOPEDIATRICS CORP.·00840194408738·Orthex Half Ring 255mm, Red
Orthex External Fixation System
FDA UDI
ORTHOPEDIATRICS CORP.·00840194408790·Orthex Half Ring 255mm, Purple
Orthex External Fixation System
FDA UDI
ORTHOPEDIATRICS CORP.·00840194408783·Orthex Half Ring 255mm, Blue
Orthex External Fixation System
FDA UDI
ORTHOPEDIATRICS CORP.·00840194408745·Orthex Half Ring 255mm, Pink
Orthex External Fixation System
FDA UDI
ORTHOPEDIATRICS CORP.·00840194408752·Orthex Half Ring 255mm, Orange
COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
CAVITY VARNISH
FDA 510(k)
FDA Class 2
·Dental