510(k) Device Clearances

RIVOS™ EUS Access Device (M00553900)

Boston Scientific Corporation

Socrates 38 Catheter

Scientia Vascular, Inc.

Sequential Circulator (SC-4004-DL, SC-4008-DL)

Bio Compression Systems, Inc.

UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips

Urit Medical Electronic Co., Ltd.

Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200

Deltronix Equipamentos Ltda

Xpert® FII & FV

Cepheid

Hypodermic Syringes & Needle

Lifelong Meditech Private Limited

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging

Canon Medical Systems Corporation

VITROS Immuodiagnostic Products CA 125 II Reagent Pack

Ortho Clinical Diagnostics

Symani Surgical System

Medical Microinstruments, Inc.

BoneView

Gleamer

1.5T HD T/R Knee Array (10-F34127)

Shenzhen RF Tech Co., Ltd.

Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44)

Shenzhen Nuon Medical Equipment Co., Ltd.

Tesera-k SC System

Kyocera Medical Technologies, Inc.

Customized Abutment

Arum Dentistry Co., Ltd.

Consolidated Operating Room Equipment (CORE) 2 Console

Stryker Instruments

OxyMinder Pro (10310)

Bio-Med Device, Inc.

NanoCeram Resin

3BFAB TEKNOLOJI A.S.

AVAVA™ Skin Treatment System

AVAVA, Inc.

FlexBand; FlexPatch; FlexBand Plus

International Life Sciences

Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic)

Pegavision Corporation

Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing

Diversatek Healthcare

Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System

Howmedica Osteonics Corp. dba Stryker Orthopaedics

IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories

Ipg Medical Corporation

See-Mode Augmented Reporting Tool, Thyroid (SMART-T)

See-Mode Technologies Pte, Ltd.

V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultra

Samsung Medison Co., Ltd.

GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]

Glove One, LLC

Silver Fluoride Hypersensitivity Varnish

Young Dental Manufacturing Co. 1, LLC

SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1

Geske Beauty Tech GmbH

BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens

Biofire Defense, LLC