16 results
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26ms
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Sources: EU EUDAMED, US FDA
BATH CLEAR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
n/a
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM51008313140161·Rotary diamond instrument for dental application
Epredia
FDA UDI
RICHARD-ALLAN SCIENTIFIC COMPANY·00673693088947·Cytoseal™ 60 is a toluene-based mounting medium...
Continuum® Trilogy®
FDA UDI
Zimmer, Inc.·00889024153349·
Continuum® Trilogy®
FDA UDI
Zimmer, Inc.·00889024153332·
Continuum® Trilogy®
FDA UDI
Zimmer, Inc.·00889024153325·
Continuum® Trilogy®
FDA UDI
Zimmer, Inc.·00889024153318·
ROGS
FDA 510(k)
FDA Class 2
·Anesthesiology
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II
FDA 510(k)
FDA Class 2
·Immunology
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120361001·Diamond, pear, medium grit
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120341121·Diamond, pear, coarse grit, green ring
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code NIQ·May 23, 2014
PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO·Product code GDW·November 1, 2012
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·September 7, 2010
PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion 7 M12, Model Number 722223. 10. Azurion 7 M20, Model Number 722224. 11. Azurion 7 B12, Model Number 722225. 12. Azurion 7 B20, Model Number 722226. 13. Azurion 5 M12, Model Number 722227. 14. Azurion 5 M20, Model Number 722228. 15. Azurion 7 M20, Model Number 722282.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025