16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
JOBST soSoft
FDA UDI
BSN MEDICAL, INC.·00035664008000·SOSOFT 30-40 KH RIB S BL 1 EN FR ES
ArgenZ HT+ 98x16
FDA UDI
ARGEN CORPORATION, THE·D818120263·Dental porcelain/ceramic restoration kit
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450021965·
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017190·Hook Scissors 2.7mm 15 degree up
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017206·Hook Scissors 3.5mm 15 degree up
LYNX
FDA UDI
HNM TOTAL RECON LLC·00841742111605·LYNX Str Locking Plate w/CombiHoles, Ti - (L)16...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197526784·DeMartel Vascular Scissors, curved
6 3/4"...
ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LOGIQ 3
FDA 510(k)
FDA Class 2
·Radiology
MBT CEM KEEL TIB TRAY SZ2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NJL·December 4, 2019
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
AGILIS INTRODUCER, UNKNOWN
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, AF DIVISION·Product code DYB·June 7, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 14, 2008
Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant VBR 2107-0218 18mm Large Endoskeleton Implant VBR 2107-0220 20mm Large Endoskeleton Implant VBR Endoskeleton TA VBR is intended for use in the thoracolumbar spine (T1-L5) to replace all or part of a collapsed, damaged, or unstable vertebral body due to tumor or trauma.
FDA Enforcement
Class II
·Terminated·TITAN SPINE, LLC·December 26, 2012
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