16 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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Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite
FDA 510(k)
FDA Class 2
·Orthopedic
PREPAIR
FDA UDI
DANVILLE MATERIALS, LLC·00816594021778·PREPAIR
METZENBAUM SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896052307·METZENBAUM SCISSORS CURVED BLADES POWER CUT BLACK
BD SYRINGE 1ML S/T W/NDL 27X1/2 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·April 16, 2024
EzRay Air Portable (Model: VEX-P300)
FDA 510(k)
FDA Class 2
·Dental
BD Univia RightFit Enteral Extension Sets and Transitional Adapters
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYNCHROMED
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·March 26, 2008
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·April 15, 2016
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014
GORE HYBRID VASCULAR GRAFT
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DSY·July 29, 2011
ARCHITECT CA 19-9XR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code NIG·July 1, 2013
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·January 4, 2016
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·December 3, 2015
UNKNOWN CAGE/SPACER
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code OVD·June 8, 2021
UNKNOWN CAGE/SPACER
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code OVD·June 8, 2021
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021