K230501

FDA 510(k)

FDA Class 2 ·Anesthesiology

FDA UDI

LEONE SPA·08033707022930·CALIBRA BANDS 2ND MOLAR n.SUL 1

FDA UDI

VB Spine LLC·10888857241947·FAST Drill Guide, Translational

FDA UDI

VASOMEDICAL, INC.·00817980020115·3 CH ECG Holter/ABP COMB Recorder w/Bluetooth

FDA 510(k)

FDA Class 2 ·Orthopedic

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FDA Adverse Event

Malfunction ·BECTON DICKINSON·Product code FMI·November 30, 2023

FDA Adverse Event

Malfunction ·CARDINAL HEALTH, INC.·Product code PNR·December 11, 2023

FDA Adverse Event

Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024

FDA Adverse Event

Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 3, 2018

FDA Adverse Event

Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 13, 2024

FDA Adverse Event

Injury ·C.R. BARD, INC. (COVINGTON) -1018233·Product code FTL·August 12, 2011

FDA Adverse Event

Injury ·DEPUY MITEK·Product code MAI·July 16, 2008

FDA Adverse Event

Malfunction ·BAXTER HEALTHCARE - THETFORD·Product code LHI·July 16, 2013

FDA Adverse Event

Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·September 22, 2023