Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE DS & 2000D FFDM SYSTEM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS Total Knee System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SYNCHROMED INFUSION SYSTEM

ESI

FDA UDI

FTT MEDICAL, INC.·B3963708120·LIGATING RINGS, PACKAGE OF 100. (Caution: This ...

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Minerva ES Endometrial Ablation System

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB/ENDOAVITENE

ROHO QUADTRO SELECT Cushion

FDA UDI

Roho, Inc.·00613732079956·Small size configuration of a ROHO QUADTRO SELE...

Amplion Care Assurance

FDA UDI

AMPLION CLINICAL COMMUNICATIONS, INC.·00850016398765·Software for Messaging Controller, Version 1.8....

ROHO Single Compartment Cushion

FDA UDI

Roho, Inc.·00613732079949·Large size configuration of a ROHO Single Compa...

Tantalum Bead Set

FDA UDI

Halifax Biomedical Incorporated·00628451892014·Tantalum bead implants are used as radio-opaque...

ROHO Single Compartment Cushion

FDA UDI

Roho, Inc.·00613732079932·Small size configuration of a ROHO Single Compa...

ROHO QUADTRO SELECT Cushion

FDA UDI

Roho, Inc.·00613732079963·Large size configuration of a ROHO QUADTRO SELE...

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MMR RxDx Panel

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MMR RxDx Panel

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MMR RxDx Panel

Calcium Arsenazo III Reagent

FDA UDI

CLINICAL DIAGNOSTIC SOLUTIONS, INC.·00812137011923·For the quantitative determination of Calcium i...

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvéderm® Volbella™ XC

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·CGMS IPRO SYSTEM