18 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED
FDA 510(k)
FDA Class 2
·Orthopedic
Chemosite
FDA UDI
Covidien LP·10884521099333·Venous Access System
OsteoMed
FDA UDI
OSTEOMED LLC·00845694002608·13mm Left L Plate
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319703243·Tissue Forceps 5-1/2" (13.8cm), 1x2 teeth
RICHARDSON ELECTRONICS
FDA registration
RICHARDSON ELECTRONICS·1 product·🇺🇸 United States
OptiMesh Multiplanar Expandable Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7403120044·Short Portal Stem
OsteoMed
FDA UDI
OSTEOMED LLC·00845694040846·13mm Left L Plate, Sterile
OsteoMed
FDA UDI
OSTEOMED LLC·00845694063555·1.2 System 13mm Left L Plate Sterile Qty 2
FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY
FDA 510(k)
FDA Class 2
·Orthopedic
VINYL EXAMINATION GLOVES STERILE POWEDERED
FDA 510(k)
FDA Class 1
·General Hospital
PRECISION NOVI?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·June 27, 2025
Widex
FDA UDI
Widex A/S·05706069543247·Compass V5.7.2 CD-ROM
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 20, 2013
NEXGEN STEMMED TIBIAL PLATE
FDA Adverse Event
Injury
·ZIMMER INC.·Product code JWH·June 7, 2011
G2 FILTER SYSTEM, FEMORAL
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·August 15, 2008
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
FDA Enforcement
Class II
·Ongoing·AURIS HEALTH INC·October 16, 2024
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 30, 2025