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