13 results
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27ms
·
Sources: EU EUDAMED, US FDA
INOCULATOR, MIC-2000 DISPOSABLE
FDA 510(k)
FDA Class 1
·Microbiology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690196396·AK3 Femoral Instruments Pan
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690195108·AK3 Femoral Instruments Pan Insert
SALTO TALARIS TOTAL ANKLE PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
FDA 510(k)
FDA Class 2
·Medical Genetics
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·May 5, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012
UNKNOWN DEPUY SCREW
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·August 5, 2010
HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·April 25, 2023
HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024