49 results · 22ms · Sources: EU EUDAMED, US FDA

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LUCEA LED SURGICAL LIGHT SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

5570 3L SYRINGE

FDA UDI
HANS RUDOLPH, INC.·00817136021577·5570 3L SYR PER SIBEL MED

Plateau Spacer System

FDA UDI
Life Spine, Inc.·00190837045791·Paddle Shaver, 7mm

AXIS PACS, HMS PACS

FDA 510(k)
FDA Class 2 ·Radiology

DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 9, 2025

CATALYS LASER

FDA Adverse Event
Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·January 24, 2024

CATALYS LASER

FDA Adverse Event
Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·July 28, 2023

ATLANTIS? SR PRO²

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code DQO·May 15, 2013

ARDIS INSERTER - 9MM

FDA Adverse Event
Malfunction ·ZIMMER SPINE·Product code MAX·September 17, 2014

THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

FDA Adverse Event
Injury ·THORATEC CORP.·Product code DSQ·June 1, 2011

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·April 24, 2026

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·October 30, 2023

CATALYS SYSTEM

FDA Adverse Event
Injury ·AMO MANUFACTURING USA, LLC·Product code OOE·November 1, 2022

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·January 26, 2026

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·July 28, 2023

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·Product code OOE·October 12, 2021

CATALYS SYSTEM

FDA Adverse Event
Injury ·AMO MANUFACTURING USA, LLC·Product code OOE·November 1, 2022

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·May 21, 2021

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·May 21, 2021