317 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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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