10 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LDH SUBSTRATE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471179543·Anatomical Molar Bands, Lower Right 1St Molars,...
Daytona Small Stature
FDA UDI
Seaspine Orthopedics Corporation·10889981156756·Laminar Hook, 12.0 x 12.0mm
ACTIVE UNICOMPARTMENTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 21, 2014
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code KPE·September 26, 2012
PUMP MMT-722NAB PRDGM INS V2.2 BL EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·July 13, 2010
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014