8112-8114 (FH Hard SUN)

FDA registration

StoH·1 product·🇰🇷 South Korea

KIDS CROWN

FDA registration

SHINHUNG CO. LTD.·1 product·🇰🇷 South Korea

Nitronox Scavenger Plus

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

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

Hp Detect™ Stool Antigen ELISA

FDA 510(k)

FDA Class 1 ·Microbiology

DeepChek® Assay INTEGRASE Genotyping and Drug Resistance

FDA registration

AdvancedDx Biological Laboratories USA Inc·1 product·🇺🇸 United States

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·PARADYM CRT-D 8750, PARADYM RF CRT-D9750 (ZL101), PARADYM RF CRT-D9750 (ZL102), INTENSIA CRT-D 174

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PARADYM VR 8750, PARADYM DR 8750, PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL101), PARADYM RF VR 9750, PARADYM RF DR 9750