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

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XENON LIGHT SOURCE PES 1

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

PICCOLO BASIC METABOLIC PANEL

FDA Adverse Event
Malfunction ·ABAXIS, INC.·Product code CGX·October 22, 2020

PICCOLO COMPREHENSIVE METABOLIC PANEL

FDA Adverse Event
Malfunction ·ABAXIS, INC.·Product code CGX·November 3, 2020

Kitazato ET Catheters

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

C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER

FDA 510(k)
FDA Class 2 ·Orthopedic

WALLSTENT RP ENDOPROSTHESIS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code JCT·March 21, 2025

XIA 3 TITANIUM TORQUE WRENCH

FDA Adverse Event
Malfunction ·STRYKER SPINE-FRANCE·Product code LXH·March 7, 2013

ATTAIN ACCESS

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code DQY·February 15, 2011

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MPRI·Product code DTB·August 8, 2014

WALLSTENT? RP ENDOPROSTHESIS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025

BA102

FDA Adverse Event
Malfunction ·NAKANISHI INC.·Product code EGS·March 31, 2016

BA105

FDA Adverse Event
Malfunction ·NAKANISHI INC.·Product code EGS·March 28, 2016

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EGS·August 29, 2017

Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016