317 results · 22ms · Sources: EU EUDAMED, US FDA

Accurate Multi Panel Drug Urine Test Cup

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Infrared Thermometer

FDA 510(k)
FDA Class 2 ·General Hospital

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

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Disposable Surgical Isolation Gown

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Arm Blood Pressure Monitor

FDA 510(k)
FDA Class 2 ·Cardiovascular

Healgen Rapid Check COVID-19/Flu A&B Antigen Test

FDA 510(k)
FDA Class 2 ·Microbiology

Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

MIMOSA Imager

FDA 510(k)
FDA Class 2 ·Cardiovascular

IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20 GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Disposable Double Lumen Endobronchial Tube

FDA 510(k)
FDA Class 2 ·Anesthesiology

Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241

FDA 510(k)
FDA Class 2 ·General Hospital

OPTI-PLAST 7F PERIPHERAL ANGIOPLASTY CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular