15 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UroLift System UL400
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QMN·September 2, 2025
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QMN·December 13, 2024
DIAMONDBACK SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SINUS QUICK EB SYSTEM
FDA 510(k)
FDA Class 2
·Dental
PFC SIGMA C/S NPOR FEM LT SZ 3
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC·Product code JWH·October 3, 2008
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·June 21, 2013
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·July 25, 2011
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QMN·December 17, 2024
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QMN·March 24, 2025
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QMN·March 14, 2025
THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·January 2, 2024
THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·January 2, 2024
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024