Connected OR Hub with Voice Control, Connected OR Hub with Device Control

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)

FDA 510(k)

FDA Class 2 ·Cardiovascular

L10 LED Light Source with AIM, L11 LED Light Source with AIM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL

FDA 510(k)

FDA Class 2 ·Radiology

HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface

FDA 510(k)

FDA Class 2 ·Cardiovascular

Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles

FDA 510(k)

FDA Class 2 ·Orthopedic

AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE

FDA 510(k)

FDA Class 2 ·Radiology

VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING

FDA 510(k)

FDA Class 2 ·General Hospital

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE

FDA 510(k)

FDA Class 2 ·Neurology

S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08

FDA 510(k)

FDA Class 2 ·Cardiovascular

Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology

FDA 510(k)

FDA Class 2 ·Orthopedic

NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE FIELD DRAPE

FDA 510(k)

FDA Class 2 ·General Hospital

TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLET

FDA 510(k)

FDA Class 2 ·Anesthesiology

Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology