11 results
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18ms
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Sources: EU EUDAMED, US FDA
QUINTON Q-TEL 418T & 419T REMOTE CARDIAC MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Empower Bracket
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746190834·DB BKT SL EMPOWER INTERACT UR CUSP 022 T-2 A+9 R=0
Empower2
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746009761·DB BKT SL EMPOWER INTERACT UR CUSP 022 T-2 A+9 R=0
Speedlock
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657004909·Outer Shaft for Speedlock, 10mm, 26cm
Clinpro Varnish
FDA 510(k)
FDA Class 2
·Dental
EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
COBAS C 503 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·March 24, 2025
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·May 23, 2014
UNIVERSAL HANDSWITCH
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·October 29, 2012
PERFORMANCE PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FPO·September 22, 2010
Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu, Cedex France. Made in Ireland. The Definition PM femoral hip stem is a forged, collared, straight stem with an integral premantle (PM) design. The Poly Methyl Methacrylate (PMMA) and Barium Sulphate (BaSO4) premantle is integral to the design as it aligns, centralizes and pressurizes the stem within the femoral canal. The forged stem is first grit blasted proximally and then the premantle is applied through an infection molding process.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 18, 2012