19 results
·
20ms
·
Sources: EU EUDAMED, US FDA
MECONIUM ASPIRATOR
FDA 510(k)
FDA Class 1
·Anesthesiology
Arthrex®
FDA UDI
ARTHREX, INC.·00888867303836·Low Profile Screw, 1.4x7mm, Cortical, Ti
LOW PROFILE SCREW, 1.4X8MM, CORTICAL, TI
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HRS·November 21, 2022
LOW PROFILE SCREW, 1.4X7MM, CORTICAL, TI
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HRS·November 21, 2022
LOW PROFILE SCREW, 1.4X9MM, CORTICAL, TI
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HRS·November 21, 2022
CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024
LUNG VOLUME & PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
ExsoMed ArcPhix and ExsoMed ArrowPhix
FDA 510(k)
FDA Class 2
·Orthopedic
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·June 6, 2018
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·June 7, 2018
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·June 6, 2018
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·April 27, 2018
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·April 16, 2018
LOW PROFILE SCREW, 1.4X7MM, CORTICAL, TI
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HRS·June 9, 2023
LOW PROFILE SCREW, 1.4X8MM, CORTICAL, TI
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HRS·June 9, 2023
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 29, 2014
ENDOPATH** XCEL*
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·October 15, 2010
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LEH·December 13, 2012
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·June 5, 2018