DENTAL EQUIPMENTS

FDA UDI

RHEIN 83 SRL·08059224128078·DISPOSABLE device in plastic material to be emb...

DENTAL ATTACHMENTS

FDA UDI

RHEIN 83 SRL·D821045ACS0·DISPOSABLE device in plastic material to be emb...

DENTAL ATTACHMENTS

FDA UDI

RHEIN 83 SRL·D821049PCNDR8·DISPOSABLE device in plastic material to be emb...

DENTAL ATTACHMENTS

FDA UDI

RHEIN 83 SRL·D821045CSMDR8·DISPOSABLE device in plastic material to be emb...

DENTAL ATTACHMENTS

FDA UDI

RHEIN 83 SRL·D821040CRNSNDR8·DISPOSABLE device in plastic material to be emb...

Safe & Soft tampons

FDA UDI

AL-BAD MASSUOT YITZHAK LTD·00834533001322·Safe & soft tampons, Super absorbency, 500 bulk...

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SIEMENS MAMMOMAT NOVATION FULL FIELD DIGITAL MAMMOGRAPHY (FFDM)SYSTEM

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·Supartz FX, Visco-3

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Master InterStim® Therapy System, Verify® Evaluation System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·SAFIRE CARDIAC ABLATION SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·EXOSEAL Vascular Closure Device

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

Prosthesis, Testicular

FDA Pre-Market Approval

FDA Class 3 ·MENTOR SALINE-FILLED TESTICULAR PROSTHESIS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·AXSYM CORE 2.0 (LN 8B88)

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·AXSYM FREE PSA (LN 3C20)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·AXSYM CORE-M 2.0 (LN 3B89)

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AXSYM AFP (LN 7A48)