10 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CREODENT SOLIDEX CUSTOM ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
Bio-Modular® Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00887868253584·
BIO-MODULAR SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304213487·
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837045937·Barrel Shaver, 7mm
WEINMANN SOMNOMASK
FDA 510(k)
FDA Class 2
·Anesthesiology
H-WAVE
FDA 510(k)
FDA Class 2
·Physical Medicine
NITE GUARD
FDA Adverse Event
Malfunction
·RANIR LLC·Product code OBR·May 1, 2014
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·May 15, 2013
MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MAF·June 3, 2011
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025