System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PATH VYSION HER-2 DNA PROBE KIT ASSAY

Thermo Scientific

FDA UDI

RICHARD-ALLAN SCIENTIFIC COMPANY·00673693194723·Monoclonal Mouse Anti-Human c-erbB-2 / HER-2 / ...

Thermo Scientific

FDA UDI

RICHARD-ALLAN SCIENTIFIC COMPANY·00673693108676·Monoclonal Mouse Anti-Human c-erbB-2 / HER-2 / ...

Thermo Scientific

FDA UDI

RICHARD-ALLAN SCIENTIFIC COMPANY·00673693386463·Monoclonal Mouse Anti-Human c-erbB-2 / HER-2 / ...

Thermo Scientific

FDA UDI

RICHARD-ALLAN SCIENTIFIC COMPANY·00673693108683·Monoclonal Mouse Anti-Human c-erbB-2 / HER-2 / ...

MammoStar™

FDA UDI

Carbon Medical Technologies, Inc.·00858015005349·Biopsy Site Identifier - Revolve

HydroMARK Breast Biopsy Site Marker

FDA UDI

DEVICOR MEDICAL PRODUCTS, INC.·00841911102168·HydroMARK Breast Biopsy Site Marker

Tumark Eye

FDA UDI

SOMATEX Medical Technologies GmbH·04250195611369·

HydroMARK Breast Biopsy Site Marker

FDA UDI

DEVICOR MEDICAL PRODUCTS, INC.·00841911102120·HydroMARK Breast Biopsy Site Marker

SmartClip

FDA UDI

Elucent Medical, Inc.·10851674008208·Soft tissue marker and delivery system, Purple,...

MammoStar™

FDA UDI

Carbon Medical Technologies, Inc.·00858015005424·Biopsy Site Identifier

Gold Marker

FDA UDI

RIVERPOINT MEDICAL, LLC·00812444027976·Brachytherapy

SCOUT®

FDA UDI

MERIT MEDICAL SYSTEMS, INC.·00884450582718·

SecurMark

FDA UDI

Hologic, Inc.·05420045503406·

BioZorb Bioabsorbable Marker

FDA UDI

Hologic, Inc.·15420045514010·BioZorb Marker 3cm x 4cm

UltraClip® Dual Trigger Breast Tissue Marker

FDA UDI

Bard Peripheral Vascular, Inc.·00801741032424·ULTRACLIP® DUAL TRIGGER  breast tissue marker, ...

HydroMark

FDA UDI

DEVICOR MEDICAL PRODUCTS, INC.·00841911101567·HydroMARK Breast Biopsy Site Marker

Achieve

FDA UDI

CAREFUSION 2200, INC·10885403242366·Achieve Gold Tissue Marker, 18g 11cm

CELEROMARK

FDA UDI

Hologic, Inc.·05420045503383·

HydroMark

FDA UDI

DEVICOR MEDICAL PRODUCTS, INC.·00841911100034·HydroMARK Breast Biopsy Site Marker