46 results · 23ms · Sources: EU EUDAMED, US FDA

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Asthma Monitor AM3

FDA 510(k)
FDA Class 2 ·Anesthesiology

NOVEL TAPERED HIP STEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BIOCRYL X

FDA 510(k)
FDA Class 2 ·Dental

CATALYS LASER

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

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 14, 2025

CATALYS LASER

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

530G INSULIN PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 18, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 29, 2011

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013

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

OPHTHALMIC FEMTOSECOND LASER

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·August 12, 2021

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·August 13, 2021