15 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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Respire Blue Series-EF
FDA 510(k)
FDA Class 2
·Dental
HairCheck-DT (Cocaine)
FDA UDI
Quest Diagnostics·00868586000216·HairCheck-DT (Cocaine) is an ELISA test kit use...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704284034·
BD LUER-LOK¿ TIP SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 28, 2022
BD LUER-LOK¿ TIP SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 11, 2022
SPIDER CERVICAL PLATING (SCP) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BD LUER-LOK¿ 10 ML BULK PACK LUER LOCK TIP WITHOUT SAFETY
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 18, 2022
FG SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY RIGHT ANGLE 5 MM
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code OWN·March 5, 2025
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 2, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code NVY·June 7, 2013
SYNCHROMED
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·June 23, 2011
BD SYRINGE LUER-LOK¿ TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 13, 2022
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026