105 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Aquilion Lightning, TSX-036A/1, V8.4
FDA 510(k)
FDA Class 2
·Radiology
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108695632·Dynamic Dental Implant Ø3.25mm L11.5mm
LEONE SPA
FDA UDI
LEONE SPA·08033707018063·CALIBRA 1ST MOLAR BANDS n.LL 19
3.3mm Locking Drill Guide
FDA UDI
Osteocentric Technologies, Inc.·00816950029509·3.3mm Locking Drill Guide
CARRARA VOLUMIA
FDA 510(k)
FDA Class 2
·Dental
PASCAL STREAMLINE PHOTOCOAGULATOR
FDA 510(k)
FDA Class 2
·Ophthalmic
INRATIO2 PT/INR PROFESSIONAL TEST STRIP
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·September 9, 2015
INRATIO2 PT/INR TEST STRIP
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·March 4, 2016
ID NOW COVID 19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·February 3, 2022
ID NOW COVID 19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·February 3, 2022
INRATIO2 PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·August 19, 2015
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 7, 2025
MR850
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 11, 2026
FISHER AND PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE·Product code BTT·September 22, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 6, 2024
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 10, 2024
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne CDx
FISHER AND PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE·Product code BTT·November 4, 2025
FISHER AND PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE·Product code BTT·November 19, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 10, 2024