9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VitriGuard
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 15, 2011
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·May 13, 2013
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·September 9, 2008
BD MICROTAINER TUBES WITH K2E (K2EDTA)
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·November 30, 2020
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022