15 results · 17ms · Sources: EU EUDAMED, US FDA

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KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER

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

Invenio

FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918134277·Surgical Gown_Raglan Sleeve_W/reinforcement_XXL...

Invenio

FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918181950·Surgical Gown_Raglan Sleeve_W/reinforcement_XXL...

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0112420·Awl Tap, 4.75 mm, Fixed Sleeve

MAGNETOM AERA AND MAGNETOM SKYRA

FDA 510(k)
FDA Class 2 ·Radiology

HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE

FDA 510(k)
FDA Class 2 ·General Hospital

INNOVAMATRIX AC WOUND DRESSING WITH ANIMAL-DERIVED MATERIAL(S)

FDA Adverse Event
Injury ·CONVATEC TRIAD LIFE SCIENCES, LLC·Product code KGN·April 23, 2026

SYRINGE S2 2ML

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·June 4, 2020

EMERALD

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·July 6, 2016

NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

FDA Adverse Event
Malfunction ·MEDTRONIC SPINE LLC.·Product code BSP·November 30, 2010

INGENIO

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 11, 2013

TOTAL ASR ACET IMP SIZE 58

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·July 2, 2014

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015