13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DESS Dental Smart Solutions
FDA 510(k)
FDA Class 2
·Dental
CoRoent
FDA UDI
Nuvasive, Inc.·00887517571014·CoRoent Ant TLIF Ti, 14x12x34mm 0°
Syntec-Taichung Non-sterile Bone Plate and Screw Implants
FDA UDI
SYNTEC SCIENTIFIC CORPORATION·04719864685044·Mini L-Plate(Right Oblique) 2.7 x T1.2mm x W7.0mm
Sklar®
FDA UDI
SKLAR CORPORATION·10649111139154·CROWN SCISS STR SERR 4"
EXPERIENCE®
FDA UDI
Gc Orthodontics America Inc.·D78824234000201·EXRC MBT 022/LL4 -12T 2A
KASIOS TCP
FDA 510(k)
FDA Class 2
·Orthopedic
Infrared Therapy System
FDA 510(k)
FDA Class 2
·Physical Medicine
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
APTIMA COMBO 2 ASSAY
FDA Adverse Event
Injury
·HOLOGIC, INC.·Product code LSL·October 8, 2025
U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB
FDA Adverse Event
Malfunction
·QINGDAO P&B CO., LTD.·Product code HEB·November 11, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 10, 2011
GYNECARE TVT SECUR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code PAH·July 23, 2013
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020