510(k) Device Clearances

MagVenture Accelerated TMS (aTMS) Therapy System

Tonica Elektronik A/S

Sperm Freezing Medium

Gimbo Medical Technology Shenzhen Co., Ltd.

TERA HARZ CLEAR

Graphy, Inc.

Disposable Surgical Gown, Disposable Reinforced Surgical Gown

Fugou County Shenxiang Manufacturing Co., Ltd.

MectaLIF Anterior Extension

Medacta International S.A.

ONCOZENE Microspheres

Varian Medical Systems, Inc.

0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line

Barbaras Development, Inc.

DESS Dental Smart Solutions

Terrats Medical SL

Ivotion Base Print

Ivoclar Vivadent, Inc.

Spectrum IQ Infusion System with Dose IQ Safety Software

Baxter Healthcare Corporation

Fetal & Maternal Monitor (F15A, F15A Air)

Edan Instruments, Inc.

3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)

3M Company

Single Use Bipolar Forceps

Hg Innovations, Ltd.

AQUA Laminoplasty Systems

ZheJiang Decans Medical Devices Co., Ltd.

rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono

Genoss Co., Ltd.

AMSafe Pre-Filled Normal Saline Flush Syringe

Amsino International, Inc.

AccuFit Lateral 2-Hole Plate

Precision Spine, Inc.

LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue El

Boston Scientific Corporation

Benchmark BMX96 Access System

Penumbra, Inc.

Freedom® Total Knee System – Titan PCK Components

Maxx Orthopedics, Inc.

Thulium Laser System (Deluxlase)

Nanjing Bestview Laser S&T Co., Ltd.

Device 300397 Putty

Geistlich Pharma AG

HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)

Hiossen, Inc.

Ponto 5 SuperPower

Oticon Medical AB

CIV-Clear cover

CIVCO Medical Instruments Co., Inc.

Aquilion Precision (TSX-304A/4) V10.14 with AiCE

Canon Medical Systems Corporation

The Oligio

Wontech Co., Ltd.

ApolloKnee

Corin U.S.A. Limited

WAVE PTA Balloon Catheter

WAVE Medical AG

AccelFix Spinal Fixation System

L&K BIOMED Co., Ltd.