8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
RADIAL HEAD IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
HAIDA HD21
FDA 510(k)
FDA Class 2
·Physical Medicine
TPH Spectra ST Flowable Composite Restorative
FDA 510(k)
FDA Class 2
·Dental
HANDLE FOR PROTECTION SLEEVES FOR SUPRAPATELLAR
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code JDS·January 22, 2021
UNKNOWN DEPUY POLY ACETABULAR LINER
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JDI·February 28, 2013
LUMAX 340 HF-T
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code MRM·February 1, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 5, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024