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Penguin Cold Therapy®

FDA UDI
Gentherm Medical, LLC·10613031862430·Cold Therapy Device

BIPOLAR ELECTRODE 24/26 FR

FDA Adverse Event
Malfunction ·KARL STORZ SE & CO. KG·Product code FAS·September 30, 2022

ENDOFLATOR 50

FDA Adverse Event
Malfunction ·KARL STORZ SE & CO. KG·Product code FCX·October 13, 2023

INTERSTIM II

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·February 3, 2018

TIPCAM1 RUBINA 30°, OPAL1 NIR/ICG, 4K 3D

FDA Adverse Event
Injury ·KARL STORZ SE & CO. KG·Product code GCJ·February 15, 2023

BRUCKER/MESSROGHLI SUPRALOOP

FDA Adverse Event
Malfunction ·KARL STORZ SE & CO. KG·Product code KNF·June 9, 2022

VIDEO-URETERO-RENOSCOPE FLEX XC

FDA Adverse Event
Malfunction ·KARL STORZ SE & CO. KG·Product code FGB·January 5, 2026

INNER CERAMIC INSULATION TUBE

FDA Adverse Event
Malfunction ·KARL STORZ SE & CO. KG·Product code FBO·April 12, 2022

FLEX. INTUBATION VIDEO SCOPE, 5.5 X 65CM

FDA Adverse Event
Malfunction ·KARL STORZ SE & CO. KG·Product code CAL·March 23, 2020

BIPOLAR ELECTRODE

FDA Adverse Event
Malfunction ·KARL STORZ SE & CO. KG·Product code FAS·July 24, 2023

BIPOLAR ELECTRODE 24/26 FR

FDA Adverse Event
Malfunction ·KARL STORZ SE & CO. KG·Product code FAS·April 19, 2023

ENDOFLATOR 50, W/INTEGRATED SCB MODULE

FDA Adverse Event
Malfunction ·KARL STORZ SE & CO. KG·Product code FCX·July 28, 2022

Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31144895 7614-T4 Single Basin Set Up Kit 31144960 7693-T4 Single Basin Set Up Kit 31144978 7766 Double Basin Set Up Kit 31145215 7896 Double Basin Set Up Kit 31145231 7897 Double Basin Set Up Kit 31145249 7897-T8 Double Basin Set Up Kit 31145298 7896-T8 Double Basin Set Up Kit 31145496 7696-T4 Single Basin Set Up Kit 31145520 7614 Single Basin Set Up Kit 31145546 7693 Single Basin Set Up Kit 31145629 7696 Single Basin Set Up Kit 31153938 7756-KST Surgical Set Up Kit 31154266 7656-KST Surgical Set Up Kit 31321097 7697 Surgical Set Up Kit 31324299 7830-HOH Surgical Set Up Kit 31451092 7600-DNV Surgical Set Up Kit 31453098 7682-MHP Surgical Set Up Kit

FDA Enforcement
Class II ·Terminated·Covidien LLC·July 29, 2015

ENDOFLATOR 50, W/INTEGRATED SCB MODULE

FDA Adverse Event
Malfunction ·KARL STORZ SE & CO. KG·Product code FCX·July 15, 2022

ENDOFLATOR 50, W/INTEGRATED SCB MODULE

FDA Adverse Event
Malfunction ·KARL STORZ SE & CO. KG·Product code FCX·July 15, 2022

BI-POLAR ELECTRODE

FDA Adverse Event
Malfunction ·KARL STORZ ENDOSCOPY-AMERICA, INC.·Product code FAS·December 22, 2022

(C-MAC VIDEO LARYNGOSCOPE MAC #3)

FDA Adverse Event
Malfunction ·KARL STORZ SE & CO. KG·Product code CCW·December 17, 2024

R26046BA

FDA Adverse Event
Malfunction ·KARL STORZ SE & CO. KG·Product code GCJ·March 10, 2025

C-MAC VIDEO LARYNGOSCOPE MAC #3

FDA Adverse Event
Malfunction ·KARL STORZ SE & CO. KG·Product code CCW·December 24, 2024

GRASPING FORCEPS, 3 FR.

FDA Adverse Event
Malfunction ·KARL STORZ SE & CO. KG·Product code OCZ·January 31, 2025