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

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CARESTREAM PACS

FDA 510(k)
FDA Class 2 ·Radiology

VUE PACS

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.·Product code LLZ·November 21, 2025

N/A

FDA UDI
Zimmer, Inc.·00889024432956·

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306811685·Lateral Retractor Blade 1 x 3"

NA

FDA UDI
Zimmer, Inc.·00889024510371·

MALE NATURAL RUBBER LATEX CONDOM

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202

FDA 510(k)
FDA Class 2 ·Radiology

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 7, 2025

MR850

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 11, 2026

FISHER AND PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE·Product code BTT·September 22, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 6, 2024

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 10, 2024

FISHER AND PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE·Product code BTT·November 4, 2025

FISHER AND PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE·Product code BTT·November 19, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 10, 2024

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Injury ·Product code BTT·February 18, 2021

MR850

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE·Product code BTT·March 26, 2026

UNKNOWN ZIMMER HIP IMPLANT

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JDI·May 9, 2013

GRANUFLO

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 8, 2014

RUSCH LITE SLIM MAC 3 BLADE

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code GEI·April 15, 2011