16 results · 20ms · Sources: EU EUDAMED, 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