510(k) Device Clearances

ClearPoint Array System (Version 1.2)

ClearPoint Neuro, Inc.

Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card

Healgen Scientific,, LLC

Innomed NPWT Silicone Foam Dressing

Zhejiang Longterm Medical Technology Co., Ltd.

Nitrile Examination Gloves (Model: ZMG1351)

Wuhan Zonsen Medical Products Co., Ltd.

Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger

Qura S.R.L

Niti-S Esophageal Stent; Esophageal TTS Stent

Taewoong Medical Co., Ltd.

ATEC Lateral Navigation Instruments

Alphatec Spine, Inc.

PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonosco

Pentax of America, Inc.

EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG

DRTECH Corporation

Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Sma

Covidien (Part of Medtronic)

A8 INTEGR8™ Porous Pedicle Screws

Allumin8, Inc.

Voluson Signature 20, Voluson Signature 18

GE Medical Systems Ultrasound and Primary Care Diagnostics

EVOS Pelvic and Acetabular System

Smith & Nephew

nView s1 with nav option

Nview Medical

Swift Ray 1

Swift Medical, Inc.

Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 w

The Magstim Company , Ltd.

VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VI

Vinno Technology (Suzhou) Co.,Ltd

Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)

Minnesota Medical Technologies

Auxo A300, A150 and APod

Auxo Hair, LLC

iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)

Shenzhen Yhlo Biotech Co., Ltd.

SERV MEDICAL CDSS

Serv Medical Pte., Ltd.

Revaclear 500, Revaclear 400, Revaclear 300

Baxter Healthcare Corporation

FBCC Night Guard

Fbcc, Inc.

Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS

Smith & Nephew, Inc.

BIOFIRE SPOTFIRE Respiratory (R) Panel

Biofire Diagnostics

OSSIOfiber® Staple

OSSIO , Ltd.

Zenition 90

Philips Medical Systems Nederlands B.V.

Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11

Shenzhen Superbio Technology Co., Ltd.

NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)

Fresenius Medical Care Renal Therapies Group, LLC

Altech® Exhalation Valve (Single Limb and Dual Limb)

Meditera Tibbi Malzeme San VE Tic AS