226 results
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56ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Magic Torque DLVR Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE Pressure Sensor
FDA 510(k)
FDA Class 2
·Cardiovascular
TORQUE DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SpyGlass Discover Retrieval Basket
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MANTIS Clip
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Tria Soft Ureteral Stent
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SpyGlass DS Direct Visualization System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WATCHMAN FXD Curve Access System
FDA 510(k)
FDA Class 2
·Cardiovascular
AdVance XP Male Sling System (720163-03)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
FDA 510(k)
FDA Class 2
·Cardiovascular
15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
FDA 510(k)
FDA Class 2
·Cardiovascular
14F iSLEEVE Introducer Set
FDA 510(k)
FDA Class 2
·Cardiovascular
Nitinol Thermocouple (TCN) Electrode
FDA 510(k)
FDA Class 2
·Neurology
ACUITY Pro Lead Delivery System
FDA 510(k)
FDA Class 2
·Cardiovascular
Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat