162 results · 25ms · Sources: EU EUDAMED, US FDA

truSculpt RF Device; truSculpt; truSculpt 3D

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

Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software

FDA 510(k)
FDA Class 2 ·Cardiovascular

MAVERICK External Fixation System

FDA 510(k)
FDA Class 2 ·Orthopedic

SURGICAL DYNAMICS DISCOGRAPHY SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

CLYDESDALE SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

LDR Spine ROI-C Cervical Cage System

FDA 510(k)
FDA Class 2 ·Orthopedic

Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)

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

CLEARLUMEN THROMBECTOMY SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)

FDA 510(k)
FDA Class 2 ·Cardiovascular

BIOFOAM BONE WEDGE

FDA 510(k)
FDA Class 2 ·Orthopedic

TSRH SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index

FDA 510(k)
FDA Class 2 ·Cardiovascular

Smith & Nephew VISIONAIRE Adaptive Guides

FDA 510(k)
FDA Class 2 ·Orthopedic

Acumen Hypotension Prediction Index (HPI) Algorithm

FDA 510(k)
FDA Class 2 ·Cardiovascular

JOURNEY II XR Knee System

FDA 510(k)
FDA Class 2 ·Orthopedic

LUMAX (MODIFICATION)

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

MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System

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

MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK

FDA 510(k)
FDA Class 2 ·Cardiovascular

High Performance Liquid Chromatography For Cyclosporine

FDA Pre-Market Approval
FDA Class 2 ·BIO-RAD CYCLOSPORINE BY HPLC TEST