36 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BINAXNOW G6PD TEST
FDA 510(k)
FDA Class 2
·Hematology
Saw Blade
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613215104·STRYKER® RECIPROCATOR BLADE REPLACEMENT
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481114502·LOCATOR F-Tx Abutment for 3.3mm CAMLOG Connecti...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481110870·LOCATOR R-Tx Abutment for 3.3mm Camlog Connecti...
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00732094282610·Cuff, Ambulo ABPM, Large Adult Long 31-40 cm ra...
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00732094258752·Cuff, Ambulo ABPM, Large Adult 31-40 cm range
EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TORNIER TOTAL ELBOW PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
Digital Breast Tomosynthesis
FDA Pre-Market Approval
FDA Class 3
·SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM, 3D
FDA Adverse Event
Malfunction
·HOLOGIC, INC·Product code OTE·January 8, 2025
Digital Breast Tomosynthesis
FDA Pre-Market Approval
FDA Class 3
·SELENIA DIMENSIONS 3D SYSTEM
Digital Breast Tomosynthesis
FDA Pre-Market Approval
FDA Class 3
·Selenia Dimensions 3D System High Resolution Tomosynthesis
Digital Breast Tomosynthesis
FDA Pre-Market Approval
FDA Class 3
·Selenia Dimensions 3D System.
Digital Breast Tomosynthesis
FDA Pre-Market Approval
FDA Class 3
·Envision Mammography Platform
Digital Breast Tomosynthesis
FDA Pre-Market Approval
FDA Class 3
·3Dimensions
Digital Breast Tomosynthesis
FDA Pre-Market Approval
FDA Class 3
·Selenia Dimensions/3Dimensions 3D System
Digital Breast Tomosynthesis
FDA Pre-Market Approval
FDA Class 3
·SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Digital Breast Tomosynthesis
FDA Pre-Market Approval
FDA Class 3
·Selenia Dimensions/3Dimensions
Digital Breast Tomosynthesis
FDA Pre-Market Approval
FDA Class 3
·Selenia Dimensions / 3Dimensions
Digital Breast Tomosynthesis
FDA Pre-Market Approval
FDA Class 3
·Envision Mammography Platform