PeraMobile and PeraWatch

FDA 510(k)

FDA Class 2 ·Cardiovascular

PERIMETER C SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit

FDA 510(k)

FDA Class 2 ·Microbiology

CD HORIZON SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMS SMART SLING SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

STERISIL ANTIMICROBIAL TUBING AND BOTTLE

FDA 510(k)

FDA Class 1 ·Dental

Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks

FDA 510(k)

FDA Class 2 ·Orthopedic

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