25 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
FDA 510(k)
FDA Class 2
·Microbiology
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022601·Dornier 600 µm Single-Use SMA UroBeam Diode Las...
CRANIAL MAP NEURO
FDA 510(k)
FDA Class 2
·Neurology
CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·January 12, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 12, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 21, 2022
DRILL, AO, STERILE 4, 2X340 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 23, 2011
COCHLEAR OSIA OSI300 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code PFO·March 8, 2026
COCHLEAR OSIA OSI300 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code PFO·January 15, 2024
COCHLEAR OSIA OSI300 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LIMITED·Product code PFO·January 15, 2024
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 18, 2011
CONNEC-ROD Ø6/3.5 L500 Ø6/250 Ø3.5/240 T
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code KWP·July 17, 2013
IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439
FDA Enforcement
Class II
·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024
IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758437
FDA Enforcement
Class II
·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024
IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758434
FDA Enforcement
Class II
·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024
IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438
FDA Enforcement
Class II
·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024
Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites.
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Technologies Ltd.·November 27, 2024
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·December 4, 2024