84 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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