16 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vivid S60N, Vivid S70N
FDA 510(k)
FDA Class 2
·Radiology
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220619000·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220619070·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220619150·
KING SEPTEMS
FDA Adverse Event
Malfunction
·KING SEPTEMS·Product code LMA·November 1, 2012
KardiFlex PTCA Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
ORTHODONTIC FLOWABLE BRACKET ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
IMP,TSV,MCOL MG,3.7MM,11M
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·December 19, 2019
BIVONA TTS TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·June 25, 2013
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 14, 2011
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 3, 2014
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
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
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020