510(k) Device Clearances

AceConnex Pre-Sutured Fascia

Allosource

TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wri

TriMed, Inc.

HARMONIC 700 Shears

Ethicon Endo-Surgery, LLC

Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))

Suite 201, National Innovation Centre

CDI OneView Monitoring System

Terumo Cardiovascular Systems Corporation

iiSure Infusion Set

Deka Research and Development

NeuroEars-Anna™

Neuroears, Inc.

da Vinci Surgical System (IS5000)

Intuitive Surgical, Inc.

BACK 3

Swims America Corp

Dark Star Deformity Pedicle Screw System

Republic Spine, LLC

Eve

Wandercraft SAS

Eko Low Ejection Fraction Tool (ELEFT)

Eko Health, Inc.

Power wheelchair (Model: JMPW-01W)

Jiangsu Jumao X-Care Medical Equipment Co., Ltd.

Air compression leg massager

Huizhou Xinyi Technology Co., Ltd.

OptraSCAN System

Optrascan, Inc.

NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter

Northeast Scientific, Inc.

MallyaG Injection Pen Adapter (MallyaG)

Biocorp Production

Blood Pressure Monitor(Model:Y30001)

Zhangzhou Easepal Medical Science and Technology Co., Ltd.

OneRF Ablation System

Neuroone Medical Technologies Corp.

FARADRIVE™ Steerable Sheath

Boston Scientific Corporation

b-ONER MOBIO Total Knee System

B-One Ortho, Corp.

Medline Smoke Evacuation Shroud

Medline Industries, Inc.

KALA Red Light Face Mask (KALA-01)

Shenzhen Kaiyan Medical Equipment Co., Ltd.

DD Hybridlayer (multicolored zirconia)

Dental Direkt GmbH

Babyroo TN300

Draeger Medical Systems, Inc.

Visible Patient Suite

Visible Patient, Sas

PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe

Poonglim Pharmatech, Inc.

FortiShield (Biosynthetic Wound Matrix)

Organogenesis, Inc.

MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box

Medimaging Integrated Solution, Inc (Miis)

Patient Monitor, models LM-8, LM-10, LM-12 and LM-15

Caf Medical Solutions, Inc.