10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HEARTWAY Power Mobility Scooter
FDA 510(k)
FDA Class 2
·Physical Medicine
Oticon
FDA UDI
Oticon A/S·05707131283436·H10V2, BTE 13 WL 85 STG
1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1
FDA 510(k)
FDA Class 2
·General Hospital
CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063
FDA 510(k)
FDA Class 2
·General Hospital
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·CARROLL HEALTHCARE·Product code FNL·June 6, 2013
HIP HEAD, 10/12 TAPER, 28MM, +0MM
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code KWY·June 29, 2011
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·October 8, 2014
BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·July 2, 2025
BD BACTEC¿ MGIT¿ 960 PZA KIT
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code MJA·November 6, 2024
BD BACTEC¿ MGIT¿ 960 PZA KIT
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code MJA·November 6, 2024