36 results · 21ms · Sources: EU EUDAMED, 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