12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
FDA 510(k)
FDA Class 1
·General Hospital
BYTE DAY ALIGNERS
FDA Adverse Event
Malfunction
·STRAIGHT SMILE, LLC·Product code NXC·October 31, 2024
C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE
FDA 510(k)
FDA Class 2
·Cardiovascular
RD SET YI
FDA Adverse Event
Malfunction
·MASIMO - 52 DISCOVERY·Product code DQA·March 29, 2021
RD SET DCI
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·February 10, 2023
ARTERIAL PRESSURE MONITORING TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code DQO·December 3, 2024
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 20, 2013
QUATTRODE LEAD WIDE SPACED, 60 CM
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code GZB·May 5, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 15, 2014
RD SET
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025
RD SET
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025