15 results · 27ms · Sources: EU EUDAMED, US FDA

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ED-344OT

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

CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738

FDA 510(k)
FDA Class 2 ·Neurology

Bone Solutions Mixing and Delivery System

FDA 510(k)
FDA Class 2 ·General Hospital

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·February 28, 2022

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·October 26, 2022

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·August 22, 2022

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·November 28, 2023

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·April 18, 2023

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·September 25, 2024

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·October 15, 2025

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·October 1, 2024

PROMUS ELEMENT¿ PLUS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·February 14, 2013

FAST-FIX/IMPLANTS

FDA Adverse Event
Malfunction ·SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE·Product code GAT·January 14, 2011

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 28, 2014

ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026