19 results · 31ms · Sources: EU EUDAMED, US FDA

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FDA 510(k)
FDA Class 2 ·Radiology

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100202·NEVYAS DRAPE SPECULUM OPEN WIRE

SUPER CHAIR FOR KIDS BY ORION

FDA 510(k)
FDA Class 1 ·Physical Medicine

N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN

FDA 510(k)
FDA Class 2 ·Immunology

Widex

FDA UDI
Widex A/S·05706069819083·Widex UNIQUE U-FS (Titan grey ) 100, Telecoil, ...

Widex

FDA UDI
Widex A/S·05706069792980·Widex UNIQUE U-PA (Titan grey ) 100, RC coil

RESTORE

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LGW·November 14, 2011

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2025

CONNECTION CABLE WL 3M

FDA Adverse Event
Injury ·RICHARD WOLF GMBH·Product code HRX·November 29, 2023

RESTORE ULTRA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 25, 2014

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 15, 2014

SURESCAN

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 18, 2015

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·July 7, 2011

TBD

FDA Adverse Event
Malfunction ·MPRI·Product code NVY·June 8, 2013

BHR

FDA Adverse Event
Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD., UK·Product code KWY·September 8, 2008

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 24, 2013

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 28, 2013

MYSPINE UNILATERAL LEFT GUIDE S01

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code PQC·August 22, 2024

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023