11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KIRO Set
FDA 510(k)
FDA Class 2
·General Hospital
Low Profile Acetabular Reamer 41
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215057442·
STINGRAY LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025
NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GE LOGIQ 7 ULTRASOUND BT05
FDA 510(k)
FDA Class 2
·Radiology
STINGRAY? LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026
PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·July 17, 2015
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Injury
·MPRI·Product code NVN·June 7, 2013
TROCHANTERIC NAIL
FDA Adverse Event
Injury
·ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·Product code HSB·July 3, 2014
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·June 22, 2011
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023