19 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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UroNav (Version 2.0)
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