510(k) Device Clearances

Montblanc Plate System

Medifield Medical Co., Ltd.

Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage

Medynus, Inc.

eCARTv5 Clinical Deterioration Suite (“eCART”)

Agilemd, Inc.

TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)

Dk Medivision Co., Ltd.

Neuro20 Pro System

Neuro20 Technologies

Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A)

Visionary Optics, LLC

Thunderbolt System

Responsive Arthroscopy, Inc.

ACS® LD FB Knee System

Implantcast GmbH

Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.

Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.

Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent car

Siemens Healthcare Diagnostics

Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)

Olympus Medical Systems Corporation

MAGNETOM Free.Max; MAGNETOM Free.Star

Siemens Shenzhen Magnetic Resonance , Ltd.

Powered Wheelchair (NXN20-208, NXN20-211)

Zhejiang Nysin Medical Co., Ltd.

VERABAND™

Arbor Medical Innovations, LLC

Aventus Thrombectomy System

Inquis Medical

AxTiHA® Stand-Alone ALIF System

Innovasis

Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs

Mah Sing Healthcare Sdn. Bhd.

Miro3D Wound Matrix

Reprise Biomedical, Inc.

AURORA Evacuator +Coag

Rebound Therapeutics

Horos MD™

Icat Solutions, Ltd.

STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette

Plasmapp Co,., Ltd.

Aptima HCV Quant Dx Assay

Hologic, Inc.

Masimo O3 Regional Oximeter

Masimo Corporation

CATALYSTEM Femoral Stems

Smith & Nephew, Inc.

Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b)

Leaseir Technologies, Slu

SmartSiteTM Vented Vial Access Device

Yukon Medical, LLC

OTC DDR

Konica Minolta Healthcare Americas, Inc.

Spectral CT Verida Family

Philips Medical Systems Technologies , Ltd.

Hoffmann LRF System

Stryker GmbH

Chemotherapy Gloves

3A Glove Sdn. Bhd.