19 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450402429·
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017879·Wide Jaw Punch large 3.5mm 7 degree up
ORGENTEC RHEUMATOID FACTOR EIA
FDA 510(k)
FDA Class 2
·Immunology
BOND-3 ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·June 10, 2011
SCORPIO NRG CR TIBIAL BEARING INSERT TRIAL #9 12MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·May 20, 2013
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - GUANGZHOU·Product code KDI·September 26, 2014
GALAXY G3 MINI 2MM X 3CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021
GALAXY G3 MINI 1.5MM X 2CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021
GALAXY G3 MINI 1.5MM X 2CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021
GALAXY G3 MINI 1MM X 3CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021
GALAXY G3 MINI 1.5MM X 3CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021
GALAXY G3 XSFT 3MM X 4CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021
GALAXY G3 MINI 1MM X 3CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021
GALAXY G3 MINI 2MM X 3CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021
GALAXY G3 MINI 1.5MM X 3CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021
GALAXY G3 MINI 1.5MM X 3CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·August 25, 2021
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