K202335

FDA 510(k)

FDA Class 2 ·Radiology

FDA UDI

Stryker Leibinger GmbH & Co. KG·07613327294378·PMD 2, DEACTIVATION INSTRUMENT

FDA UDI

OSTEOMED LLC·00845694041478·3.5mm Angled Locking/Compression Drill Guide

FDA UDI

KATENA PRODUCTS, INC.·00841668112854·VIDAURRI FLUID RETENTION WELL 8.7MM

FDA UDI

Ortho Organizers, Inc.·00190707184070·Accufit Molar Bands Lower Left Second Molar 33 1/2

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FDA 510(k)

FDA Class 2 ·Orthopedic

FDA Adverse Event

Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·January 10, 2024

FDA Adverse Event

Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·October 30, 2023

FDA Adverse Event

Other ·AMSINO MEDICAL USA·Product code NGT·October 16, 2008

FDA Adverse Event

Injury ·COVIDIEN, FORMERLY TISSUE SCIENCE·Product code FTL·June 21, 2013

FDA Adverse Event

Injury ·W.L. GORE & ASSOCIATES·Product code MIH·August 8, 2011

FDA Adverse Event

Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·October 27, 2023

FDA Adverse Event

Injury ·BOSTON SCIENTIFIC CORPORATION·Product code PCU·June 18, 2024