19 results · 20ms · Sources: EU EUDAMED, US FDA

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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