9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDELA NAMUAL BREAST PUMP
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CONNECT FOR DA VINCI SURGICAL SYSTEM(S)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HERCULES ARM
FDA Adverse Event
Malfunction
·ESTECH·Product code DWS·February 21, 2014
UNKNOWN DEPUY PFC CUP
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code KWA·November 8, 2012
SECURA DR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code LWS·September 2, 2010
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019