10 results · 19ms · Sources: EU EUDAMED, US FDA

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VITAL COUGH

FDA 510(k)
FDA Class 2 ·Anesthesiology

ArgenZ HT+ 100x18

FDA UDI
ARGEN CORPORATION, THE·D818120277·Dental porcelain/ceramic restoration kit

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 7, 2022

INTERFUSE T INVERTEBRAL BODY FUSION DEVICE

FDA 510(k)
FDA Class 2 ·Orthopedic

SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER

FDA 510(k)
FDA Class 2 ·Cardiovascular

OT VERIO FLEX METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2018

OBTRYX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 20, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2014

TREK CORONARY DILATATION CATHETER

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code LOX·June 10, 2011

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