MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator

FDA 510(k)

FDA Class 2 ·Dental

JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST

FDA 510(k)

FDA Class 2 ·Dental

NATURAL RUBBER LATEX MALE CONDOMS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator

FDA 510(k)

FDA Class 2 ·Radiology

Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator

FDA 510(k)

FDA Class 2 ·Radiology

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

CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant

FDA 510(k)

FDA Class 2 ·Radiology

MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART.

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Quantum Mitohormesis (QMT) (M2101)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Somnowell Mandibular Advancement Appliance (MAA)

FDA 510(k)

FDA Class 2 ·Dental

TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants

FDA 510(k)

FDA Class 2 ·Radiology

RUBBER CONTRACEPTIVE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Genadyne DUO NPWT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant

FDA 510(k)

FDA Class 2 ·Radiology

STETH-SHIELD(TM)

FDA 510(k)

FDA Class 2 ·Cardiovascular