18 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
FDA 510(k)
FDA Class 2
·Dental
24PW - Hanta Virus
FDA UDI
Certified Safety Manufacturing, Inc.·00766588013442·Hanta Virus - 24 Poly White
24M - Southwest Gas Corp
FDA UDI
Certified Safety Manufacturing, Inc.·00766588010441·24M - Southwest Gas Corp
COZART EIA COTININE URINE KIT
FDA 510(k)
FDA Class 1
·Clinical Toxicology
HAC-300 HEAD ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
SYNERGY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·April 25, 2023
EQUINOXE
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code KWT·September 25, 2019
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 17, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCO·Product code CBK·June 27, 2013
NW ABLATION SYSTEM, US
FDA Adverse Event
Injury
·NEUWAVE MEDICAL, INC.·Product code NEY·July 9, 2021
CD HORIZON LEGACY SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·April 11, 2020
NEUWAVE PR PROBE 15CM 17GA
FDA Adverse Event
Injury
·NEUWAVE MEDICAL, INC.·Product code NEY·July 9, 2021
GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code NIO·March 18, 2020
GORE VIABAHN ENDOPROSTHESIS - 3
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code PFV·March 18, 2020
EXCOR BLOOD PUMP PU VALVES,15 ML IN/OUT Ø9 MM
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·July 25, 2019
SYNERGY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·April 25, 2023
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021