esolution

FDA 510(k)

FDA Class 2 ·Cardiovascular

esolution® Esophageal Retractor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation

FDA classification

FDA Class 2 ·Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation

QCU ANALYTICAL SOFTWARE PACKAGE

FDA 510(k)

FDA Class 2 ·Radiology

MXU-125 OR TMX-125

FDA 510(k)

FDA Class 2 ·Radiology

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)

FDA 510(k)

FDA Class 2 ·Dental

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SAFECARE® THC Urine Strip Test

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Powered Muscle Stimulator (Model name:MagGraver F200)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ancora Nerve Block Catheter Set

FDA 510(k)

FDA Class 2 ·Anesthesiology

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Pelvic Floor Muscle Stimulator

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS

FDA 510(k)

FDA Class 2 ·Anesthesiology

QUEX ED; QUEX S

FDA 510(k)

FDA Class 2 ·Neurology

Dental Image Plate Scanner, Model DFC-4T-SMART

FDA 510(k)

FDA Class 2 ·Dental