System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

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

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·VOYAGER OTW CORONARY DILATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·D114S OTW BALLOON DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK OTW/RANGER PTCA CATHETERS

Susceptibility Test Powders, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·STREPTOMYCIN SUEFATE DIAGNOSTIC SUSCEPTIBILITY POW

EZ-Injec LDV Sterile Safety Needle

FDA 510(k)

FDA Class 2 ·General Hospital

INUMI™ Flex Needle

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

STERiJECT Low Dead Space, STERiJECT The Invisible Needle

FDA 510(k)

FDA Class 2 ·General Hospital

ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NANOKNIFE SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Electroporation System (N3000)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ONCOBIONIC SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NanoKnife System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ONCOBIONIC SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NanoKnife System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle

FDA 510(k)

FDA Class 2 ·General Hospital