19 results
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41ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BETA-TCP GRANULES
FDA 510(k)
FDA Class 2
·Orthopedic
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564030559·HIP A
5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/65MM
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code JDP·August 28, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 26, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·March 2, 2015
IMPLANT, FIXATION DEVICE CONDYLAR PLATE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code JDP·February 23, 2017
PRIMAL OK INTERSPINOUS FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)
FDA 510(k)
FDA Class 2
·Neurology
GOLDEN COMFORTER
FDA Adverse Event
Malfunction
·GOLDEN TECHNOLOGIES, INC.·Product code INO·October 3, 2012
IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code JDP·June 1, 2015
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 20, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·June 10, 2011
4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code HRS·July 24, 2015
2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/LEFT
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·October 11, 2018
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·August 12, 2016
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·October 1, 2015
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
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021