16 results · 26ms · Sources: EU EUDAMED, US FDA

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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