10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR
FDA 510(k)
FDA Class 2
·Cardiovascular
JOBST UltraSheer
FDA UDI
BSN MEDICAL, INC.·00035664215361·ULTRA SHEER 20-30 MM HG WAIST HIGH MATERNITY ME...
SafeGuide® Single
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734023259·Disposable Over the Guidewire Esophageal Dilato...
DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGR
FDA 510(k)
FDA Class 1
·General Hospital
2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-MEDIUM
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·January 15, 2019
2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HRS·May 21, 2013
THERAKOS XTS SYSTEM
FDA Adverse Event
Malfunction
·THERAKOS, INC.·Product code LNR·July 29, 2014
ADJ PIN COLLET 2.0-3.2MM
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·May 6, 2011
Artis Q biplane, Model Number 10848282
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022