13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXTERNAL ARTICULATION
FDA 510(k)
FDA Class 2
·Orthopedic
VerSys®
FDA UDI
Zimmer, Inc.·00889024135734·
Lacrimal Chisel
FDA UDI
KATENA PRODUCTS, INC.·00841668108581·WEST LACRIMAL CHISEL STRAIGHT
TOTAL BILIRUBIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BARRIER LAPAROTOMY SHEET 450
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNKNOWN SCREW
FDA Adverse Event
Injury
·.·Product code KWY·November 19, 2018
DURATA STS OPTIM PASSIVE FIXATION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·April 30, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 26, 2007
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code IOR·October 11, 2012
ARCOS CON SZ A STD 50MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·November 19, 2018
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
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
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025