11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAPSURE(R) PS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
M-Flex®
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734020135·Blue Silicone Tungsten Maloney Esophageal Dilat...
REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162
FDA 510(k)
FDA Class 2
·Dental
AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE
FDA 510(k)
FDA Class 2
·Cardiovascular
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·October 2, 2018
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·October 2, 2018
PRIMEADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 20, 2013
UNKNOWN HIP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·September 26, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 10, 2011
HAWKINS II FLEXSTRAND BLN 20GA X 10CM
FDA Adverse Event
Injury
·ARGON MEDICAL DEVICES·Product code GDM·January 17, 2022
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