14 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AXTi Titanium Stand-Alone ALIF System
FDA 510(k)
FDA Class 2
·Orthopedic
AVANOS
FDA UDI
Avanos Medical, Inc.·00193493933334·AVANOS* Single-Shot Epidural Trays
Bernafon
FDA UDI
Bernafon AG·05711584078655·AQ CO9 MNR T, 2.4G NFM DPB MSIL ACCUQ
Halyard
FDA UDI
Avanos Medical, Inc.·10680651933338·HYH,EP TRY,S-SHOT,-,-,10
EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
FDA 510(k)
FDA Class 2
·Cardiovascular
THE CANARY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
POLYMOBIL PLUS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS AG·Product code IZL·February 24, 2026
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 14, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·June 23, 2011
11 CM ANGLE ATTACHMENT QD11
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 17, 2014
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 26, 2018
COREVALVE TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 26, 2018
MOBILETT ELARA MAX
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE GMBH·Product code IZL·December 18, 2020
Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017