10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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InActiv Blue
FDA 510(k)
FDA Class 2
·Microbiology
FLOWLINE BIOPORE EPTFE VASCULAR GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
B&J DVT Foot Garments, Models 820 Series
FDA 510(k)
FDA Class 2
·Cardiovascular
MECTALIF ANT - LAG
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·April 12, 2024
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 5, 2008
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·August 24, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 11, 2013
PLATE BRUCELLA AGAR 5% HBL 90MM 20
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code KZI·April 19, 2023
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025