84 results · 28ms · Sources: EU EUDAMED, US FDA

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CAAS Workstation

FDA 510(k)
FDA Class 2 ·Radiology

BALANCE HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304268692·

Suprasorb P Sensitive Ag

FDA UDI
L&R USA INC.·04063591428345·

Ophthalmic Retractor

FDA UDI
KATENA PRODUCTS, INC.·00841668100943·JAFFE LID RETRACTOR SMALL

ILO

FDA UDI
ILO electronic GmbH·04250369707324·300W xenon light source

Prelude EASE™ Hydrophilic Sheath

FDA UDI
Merit Medical Systems, Inc.·00884450288016·

HARDYDISK AST DORIPENEM 10 UG

FDA 510(k)
FDA Class 2 ·Microbiology

PASCAL STREAMLINE PHOTOCOAGULATOR

FDA 510(k)
FDA Class 2 ·Ophthalmic

ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·November 11, 2020

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

SECURE ACUTE CARE BED 3/01

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 20, 2013