18 results · 23ms · Sources: EU EUDAMED, US FDA

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CarpX

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Olympus

FDA UDI
Gyrus ACMI, LLC·00821925045941·nCare 4K 21.5" Medical Touch Panel

ACUMED

FDA UDI
Acumed LLC·10806378014529·2.7mm x 18.0mm Locking Cortical Screw

ACUMED

FDA UDI
Acumed LLC·10806378014536·2.7mm x 18.0mm Locking Cortical Screw

MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

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

Non-contact Infrared Body Thermometer, model:HTD8823US

FDA 510(k)
FDA Class 2 ·General Hospital

COCR HEAD 28/+4 'L' 12/14

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code MEH·January 26, 2026

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 24, 2014

ATTAIN OTW

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

RESERVOIR 3ML

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 1, 2013

PATIENT INTERFACE NIM4CPB1 NIM 4.0

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·October 28, 2025

PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·September 26, 2024

STIMULATOR, ELECTRICAL, EVOKED RESPONSE

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·July 31, 2023

NIM 4.0 CONSOLE

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·September 5, 2025

NIM 4.0 CONSOLE

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·August 2, 2024

NIM 4.0 CONSOLE

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·May 20, 2025

MECTALIF TRANSFORAMINAL CAGES TIPEEK

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code MAX·April 25, 2025

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021