K173255

FDA 510(k)

FDA Class 2 ·Orthopedic

FDA UDI

I.T.S. GmbH·09120034308123·Cancellous Screw, Cannulated, D=7,3mm, L=55mm,

FDA UDI

SKLAR CORPORATION·10649111048685·LAHEY FCP STR 5 1/2"

FDA UDI

ENDOTEC, INC.·00814193023650·B-P HIP SELF-ALIGNING ACETABULAR CUP & BEARING ...

FDA 510(k)

FDA Class 2 ·Cardiovascular

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

FDA Adverse Event

Malfunction ·TANDEM DIABETES CARE·Product code QFG·October 14, 2022

FDA Adverse Event

Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 16, 2026

FDA Adverse Event

Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·June 7, 2013

FDA Adverse Event

Injury ·ZOLL MANUFACTURING CORPORATION·Product code MVK·September 23, 2014

FDA Adverse Event

Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 23, 2011

FDA Adverse Event

Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 3, 2026

FDA Adverse Event

Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 1, 2017

FDA Adverse Event

Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 23, 2026