15 results
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28ms
·
Sources: EU EUDAMED, US FDA
3D-SHAPER
FDA 510(k)
FDA Class 2
·Radiology
FPS
FDA UDI
Tyber Medical, LLC·00810040686146·Ø2.5mm Non-locking Screw, 22mm
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251022200·ceraMotion® Ti Base Dentin A2, 20 g / dental ce...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251022400·ceraMotion® Ti Base Dentin A2, 40 g / dental ce...
Intraluminal Applicator Set
FDA 510(k)
FDA Class 2
·Radiology
GAMMAPLAN
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
aap Implantate AG·04042409194412·Cortical Screw 2.5, self-tapping, L 22
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 9, 2025
AIRCAST
FDA Adverse Event
Injury
·DJO LLC·Product code KNP·April 20, 2026
GORE® EXCLUDER® AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·April 19, 2018
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·September 8, 2011
STYLE 120 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Death
·ALLERGAN·Product code FTR·November 5, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 29, 2013
Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for implantation with bone cement, with the exception of the porous coated femoral components which can be used cemented or uncemented (biological fixation).
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·March 30, 2016
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021