23 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variobase Abutment for Bars/Bridges, RN Straumann Variobase Abutment for Bars/Bridges, WN Straumann Variobase Abutment for Bars/Bridges
FDA 510(k)
FDA Class 2
·Dental
AGXO
FDA UDI
Oticon A/S·05707131279811·H330, DESIGNRITE 10 WL SOR AGXO
E-BASIC SINGLE BREAST PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 4, 2020
ZEPHYR XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·January 13, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013
AUGMENTED INSERT
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code KWA·June 30, 2011
NRG TRANSSEPTAL NEEDLE
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·December 22, 2020
ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code OAE·November 20, 2017
FLEXCATH ADVANCE STEERABLE SHEATH
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code DRA·November 20, 2017
ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code OAE·November 20, 2017
ACHIEVE MAPPING CATHETER
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code DRF·November 20, 2017
RELIANT BALLOON
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code DQY·December 5, 2024
ENDURANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·December 5, 2024
UNK - PLATES: ANTERIOR TENSION BAND
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·September 7, 2021
UNK - CONSTRUCTS: EXPEDIUM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code MNH·September 7, 2021
UNK - PLATES: 2.7 MM LCP
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·February 2, 2024
Precise Digital Accelerator Delivery of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 26, 2012
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013