4,477 results
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48ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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DURADIAGNOST
FDA 510(k)
FDA Class 2
·Radiology
DORA Disposable A.V. Fistula Needle Sets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel
FDA 510(k)
FDA Class 2
·Clinical Toxicology
IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Biliary Pancreaticobiliary Scope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Injectable Root Canal Bioceramic Sealer (i-MTA SP)
FDA 510(k)
FDA Class 2
·Dental
Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Fingertip Pulse Oximeter
FDA 510(k)
FDA Class 2
·Cardiovascular
uPMR 790
FDA 510(k)
FDA Class 2
·Radiology
Powered Wheelchair (NXN20-205, NXN20-205M)
FDA 510(k)
FDA Class 2
·Physical Medicine
Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Electric Breast Pump, model: YM-8166
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)
FDA 510(k)
FDA Class 2
·Neurology
BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SPEED 808 DIODE LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System
FDA 510(k)
FDA Class 2
·Radiology
OTC EMS STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
Electrically powered wheelchair
FDA 510(k)
FDA Class 2
·Physical Medicine