17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VENUS SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564030474·Linen Pack, Heart
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00810019800450·Linen Pack, Heart
ArgenZ HT+ 95x16
FDA UDI
ARGEN CORPORATION, THE·D818120270·Dental porcelain/ceramic restoration kit
JOBST soSoft
FDA UDI
BSN MEDICAL, INC.·00035664008086·SOSOFT 30-40 MM HG KNEE HIGH RIB EXTRA LARGE SA...
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529584863·Apex Tibial Nail Ø 12 x 270mm
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10885425321179·STERILE SUTURE TRAY
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017237·45 degree Hook Scissors 3.5mm right angled
ALLO SOURCE/UROMED CORP.
FDA Adverse Event
Malfunction
·ALLO SOURCE/UROMED CORP.·Product code MNG·March 17, 1999
ARTISAN AESTHETIC SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·March 9, 2020
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 4, 2011
PINN SECTOR W/GRIPTION 50MM
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 20, 2013
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2014
MESH - VENTRALEX
FDA Adverse Event
Injury
·DAVOL INC.·Product code FTL·May 31, 2011
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