11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Traxcess Pro 14 Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
VERIFY 270FP CHALLENGE PACK
FDA 510(k)
FDA Class 2
·General Hospital
PACP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BIPAP A30-S SILVER
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·September 25, 2024
BIPAP A30, SILVER
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·September 25, 2024
BIPAP A30
FDA Adverse Event
Death
·RESPIRONICS, INC.·Product code MNS·September 13, 2023
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 8, 2013
LEAVE ACTIVE PFC PLI 10MM SZ5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·September 5, 2008
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DRY·June 17, 2011
BIPAP A30-S SILVER
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·September 25, 2024
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023