Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL, THERMOCOOL ST

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR DS, CELSIUS DS, EZ STEER NAV DS, NAVISTAR RMT DS, CELSIUS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR THERMOCOOL, CELSIUS THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL,CELSIUS RMT THERMOCOOL, THERMOCOOL

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS FLUTTERS, CELSIUS, CELSIUS RMT, EZ STEER 4MM NON-NAV, EZ STEER DS, CELSIUS FLUTTERS

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

PATIENT EXAMINATION GLOVES (LATEX)

FDA 510(k)

FDA Class 1 ·General Hospital

UNO 30

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

UNO Negative Pressure Wound Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

UNO Negative Pressure Wound Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PATIENT EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

PATIENT EXAMINATION GLOVES (LATEX)

FDA 510(k)

FDA Class 1 ·General Hospital

NATURAL RUBBER LATEX MALE CONDOMS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PERINATAL COMPUTER SYS MODEL 100A & 100B

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PERINATAL COMPUTERS 2015/2025/2040/2045/2080/2085

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Quantum Mitohormesis (QMT) (M2101)

FDA 510(k)

FDA Class 2 ·Physical Medicine

LATEX EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

TIGR SURGICAL MESH , MODEL WK-6

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRIGLYCERIDES GPO-PAP

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Scanostics UTI Check Application Test System

FDA 510(k)

FDA Class 1 ·Clinical Chemistry