166 results · 23ms · Sources: EU EUDAMED, US FDA

Human Lubricant

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Mobility Scooter (JT10)

FDA 510(k)
FDA Class 2 ·Physical Medicine

Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Disposable Endoscope Valves System

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12)

FDA 510(k)
FDA Class 2 ·Physical Medicine

CerebralGo Plus

FDA 510(k)
FDA Class 2 ·Radiology

TaiChiA

FDA 510(k)
FDA Class 2 ·Radiology

TaiChiB

FDA 510(k)
FDA Class 2 ·Radiology

IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)

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

Upper Arm Electronic Blood Pressure Monitor

FDA 510(k)
FDA Class 2 ·Cardiovascular

PerfusionGo Plus

FDA 510(k)
FDA Class 2 ·Radiology

Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Q-Switched Nd:YAG Laser (SHE-LSP101-1)

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

IRENE Cannulated Screw System

FDA 510(k)
FDA Class 2 ·Orthopedic

Infrared Forehead Thermometer

FDA 510(k)
FDA Class 2 ·General Hospital

IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)

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

Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle

FDA 510(k)
FDA Class 2 ·General Hospital

FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE)

FDA 510(k)
FDA Class 2 ·Cardiovascular

FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)

FDA 510(k)
FDA Class 2 ·Cardiovascular

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator