11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Lancing System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102442·NAGAHARA ANIS MANIPULATOR/CHOPPER D-E
CT OIA
FDA 510(k)
FDA Class 1
·Microbiology
Impella XR Sheath Set
FDA 510(k)
FDA Class 2
·Cardiovascular
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·September 1, 2023
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 23, 2014
UNKNOWN DEPUY PINNACLE METAL LINER
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD·Product code LPH·August 18, 2011
QUANTA SYSTEM S.P.A.
FDA Adverse Event
Malfunction
·QUANTA SYSTEM, S.P.A.·Product code GEX·December 21, 2012
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·April 26, 2017