85 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions.
FDA Recall
Open, Classified
·Straight Smile, LLC·Product code NXC·November 4, 2024
daVinci Harmonic ACE Curved Shears
FDA Recall
Open, Classified
·Intuitive Surgical, Inc.·Product code NAY·January 16, 2019
Virus Counter Platform with Model Name VC3100
FDA Recall
Open, Classified
·Sartorius Corporation·Product code REQ·March 11, 2022
Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.
FDA Recall
Open, Classified
·Argon Medical Devices, Inc·Product code DYB·July 8, 2021
Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023
Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
FDA Recall
Open, Classified
·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023