16 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
FDA 510(k)
FDA Class 2
·Orthopedic
SafeGuide® Single
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734023297·Disposable Over the Guidewire Esophageal Dilato...
FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE
FDA 510(k)
FDA Class 2
·Radiology
VICTORY XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code LWP·January 13, 2014
LEAD MODEL UNKNOWN
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·May 21, 2013
INTELLIVUE MULTI MEASUREMENT SERVER X2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·May 6, 2011
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·May 4, 2016
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·May 4, 2016
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·May 4, 2016
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·October 16, 2025
TFNA FEM NAIL Ø11 R 130° L360 TIMO15
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·February 23, 2023
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·April 5, 2018
6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HTO·April 23, 2015
DRILL STOP
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code FZX·April 23, 2015
Artis Q biplane, Model Number 10848282
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022