13 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LightForce Orthodontic System
FDA 510(k)
FDA Class 2
·Dental
7F LAUNCHER GUIDE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
RAPID STRAND RX
FDA 510(k)
FDA Class 2
·Radiology
BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 13, 2018
SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE
FDA Adverse Event
GENZYME BIOSURGERY (SEPRAFILM/PACK)·Product code MCN·August 2, 2011
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.,·Product code CBK·August 6, 2014
M2A-MAGNUM MOD HD SZ 48MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 12, 2013
BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 14, 2018
BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 17, 2018
BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 17, 2018
BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 20, 2018
BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 13, 2018
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018