19 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AVIEW Modeler
FDA 510(k)
FDA Class 2
·Radiology
Phasix
FDA UDI
Davol Inc.·00801741107634·Phasix Mesh, 8" x 16" (20 cm x 40 cm), Rectangle
Ceramco® II Silver™
FDA UDI
Dentsply International Inc.·D0011920400·
LMA AIRWAY MANAGEMENT
FDA UDI
TELEFLEX INCORPORATED·15060112319997·LMA Protector™ Cuff Pilot™ Size 4
LMA AIRWAY MANAGEMENT
FDA UDI
TELEFLEX INCORPORATED·15060112317986·LMA Protector™ Cuff Pilot™ Size 4
LMA AIRWAY MANAGEMENT
FDA UDI
TELEFLEX INCORPORATED·05060112313868·LMA Protector™ Cuff Pilot™ Size 4
OsteoMed
FDA UDI
OSTEOMED LLC·00845694015431·2.0mm x 40mm Cannulated Lag Screw
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741920400·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674192040060·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694070461·Cannulated 2.0 x 40mm Lag Screw Sterile Qty 2
PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240
FDA 510(k)
FDA Class 2
·General Hospital
AQUILEX FLUID CONTROL SYSTEM
FDA Adverse Event
Malfunction
·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020
FREESTYLE LITE
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 7, 2008
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·August 4, 2011
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 20, 2013
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025