11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BeShape One Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD BBL™ Sensi-Disc™ Amoxicillin/Clavulanic Acid 20/10 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902316282·BD BBL™ Sensi-Disc™ Amoxicillin/Clavulanic Acid...
MIS Precision Chevron Bunion System
FDA 510(k)
FDA Class 2
·Orthopedic
Panda iRes Warmer, Giraffe Warmer
FDA 510(k)
FDA Class 2
·General Hospital
Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-quantitative in vitro susceptibility testing
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
EVERSENSE SENSOR
FDA Adverse Event
Malfunction
·SENSEONICS INC.·Product code SBA·October 18, 2025
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·November 13, 2008
CLARION
FDA Adverse Event
Malfunction
·ADVANCED BIONICS, LLC·Product code MCM·August 18, 2011
PELVICOL ACELLULAR COLLAGEN MATRIX
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE·Product code FTL·July 12, 2013
Sensi Disc Amoxicillin with Clavulanic Acid 20/10 g, Catalog No. 231628 and 231629. These discs are used for semi-quantitative in vitro susceptibility testing
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021