17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Diode Laser Therapy Systems
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MiniDam
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2203811·Gingival guard, silicone. Content: 20 Pieces
EXPANDABLE KNEE
FDA 510(k)
FDA Class 2
·Orthopedic
Q50 PLUS STENT GRAFT BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
GLIDEWELL HT IMPLANT Ø4.3 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·September 3, 2025
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
GLIDEWELL HT IMPLANT Ø4.3 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·September 15, 2025
GLIDEWELL HT IMPLANT Ø4.3 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·August 25, 2025
GLIDEWELL HT IMPLANT Ø4.3 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·September 3, 2025
GLIDEWELL HT IMPLANT Ø4.3 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT INC.·Product code DZE·April 16, 2025
GLIDEWELL HT IMPLANT Ø4.3 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·April 30, 2025
INFINITI VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 31, 2008
WIDE PORE POLYPROPELENE PRODUCT
FDA Adverse Event
Injury
·AMS·Product code FTL·August 17, 2011
ATLAS II PLUS DR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025