10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)
FDA 510(k)
FDA Class 2
·Immunology
SIGMA
FDA UDI
DEPUY (IRELAND)·10603295242215·SIGMA TIBIAL INSERT ROTATING PLATFORM TC3 SIZE ...
Stryker OrthoMap Precision Knee system
FDA 510(k)
FDA Class 2
·Neurology
MALE REMEEX SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·February 14, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 29, 2014
PFC SIGMA TC3 FEM RT SZ3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·January 7, 2011
CONTOUR ACETABULAR RECONSTRUCTION RING
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDJ·June 6, 2025
MESH, SURGICAL, ACETABULAR, HIP, PROSTHESIS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDJ·January 23, 2026
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·July 10, 2024