15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Phantom XL Insulated Dilators
FDA 510(k)
FDA Class 2
·Neurology
BD BBL™ Sensi-Disc™ Piperacillin/Tazobactam 100/10 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902316916·BD BBL™ Sensi-Disc™ Piperacillin/Tazobactam 100...
Single-Use Surgical Mask With Ear Loop
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MERIT MAK (MINI ACCESS KIT)
FDA 510(k)
FDA Class 2
·Cardiovascular
STYLE 110 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·February 3, 2022
BD BBL¿ SENSI-DISC¿ PIPERACILLIN/TAZOBACTAM - 100/10 ¿G
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code JTN·April 24, 2024
STYLE 110 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·January 14, 2025
MINIMED 530G WITH ENLITE
FDA Adverse Event
Injury
·MEDTRONIC·Product code OYC·October 31, 2014
ATLAS PLUS DR
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 1, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·July 17, 2013
BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231691 and 231692¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
STYLE 110 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·January 16, 2025
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code CCK·November 29, 2022
BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231691 and 231692
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022