11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HOWMEDICA VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTS
FDA 510(k)
FDA Class 2
·Orthopedic
Medegen Medical Products, LLC
FDA UDI
MEDEGEN MEDICAL PRODUCTS, LLC·00673844002877·Bag: Ac 28x45 2.0Ml Red Pr 200/Cs
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192459·Apex Revision Knee Reamer – ZIMMER LONG FLUTES,...
Elite® Buccal Tubes Direct Bond
FDA UDI
Ortho Organizers, Inc.·00190707074531·Elite®.022 EDGE L7R MINI HK DB
ADAPTER NUT
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·March 15, 2011
SENTINEL IRON LIQUID
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MR Core Software
FDA 510(k)
FDA Class 2
·Radiology
UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code CDD·February 8, 2013
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·January 6, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 22, 2014
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024