510(k) Device Clearances

More-Cell-System

Agency For Medical Innovations GmbH

da Vinci SP Surgical System (SP1098)

Intuitive Surgical, Inc.

Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14

Poly Medicure Limited

Dexus Prosthetic System (MSL2, MSR2)

Zhejiang Qiangnao Technology Co.,Ltd

KLS Martin Orthopedic Implants - MR Conditional

KLS-Martin L.P.

iASSIST Knee System

Orthosoft D/B/A Zimmer Cas

Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)

Medical Brands Laboratories B.V.

RIA Safeguard

Ria Tech Co., Ltd.

Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)

Betters(Suzhou) Medical Co., Ltd.

ClearRead Xray Pneumothorax

Riverain Technologies, Inc.

ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter

Reshape Lifesciences

TheRay Collared and Collarless Femoral Stem

Nextstep Arthropedix

FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)

Cardio Flow Inc.,

DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)

STERIS Corporation

Disposable Radiofrequency Cannula

ABBOTT MEDICAL

Clearblue ® Early Pregnancy Test

Spd Swiss Precision Diagnostics GmbH

Nova Max Creat eGFR Monitoring System

Nova Biomedical Corporation

Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112)

Shenzhen Finicare Co., Ltd.

Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (O

Fisher & Paykel Healthcare, Ltd.

Sphincterotome

Taewoong Medical Co., Ltd.

Medline UNITE® REFLEX® Nitinol Staple System

Medline Industries, LP

LifeVac

Lifevac, LLC

VX1+

Volta Medical

Terumo Advanced Perfusion System 1

Terumo Cardiovascular Systems Corporation

InRoad® Dental Synthetic Bone Graft

Osteogene Tech Corp

2D Hip Planning Software

One Ortho

Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)

Prevest Denpro Limited

DRI TM Tricyclics Serum Tox Assay

Microgenics Corporation

EVOLVE Nitric Oxide Delivery System

Malinckrodt Manufacturing, LLC

HydroMID 4F Single Lumen Midline Catheter

Access Vascular, Inc.