510(k) Device Clearances

Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1)

Surgify Medical OY

SPECTRUM GV Bone Cement

Osteoremedies, LLC

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)

Canon Medical Systems Corporation

Super Upper Limbs Versalock Plating System

GM Dos Reis Industria e Comercio Ltda.

Levo Gen 2 Tinnitus Therapy System

Levo Medical Corporation

TRAP EASY

H.S Hospital Service S.P.A

Goody Gloves, Wincare, TBG Gloves

Thai Rubber Gloves Co., Ltd.

Non-Mydriatic Retinal Camera NW500

Topcon Corporation

MCL 31 Dermablate System

Asclepion Laser Technologies GmbH

MonoStereo

Medicaltek Co., Ltd.

Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green);

Wrp Asia Pacific Sdn. Bhd.

Demetra Dermatoscope BDEM-01

Barco N.V.

LimFlow ARC

LimFlow, Inc.

TERA HARZ DENTURE

Graphy, Inc.

Carescape Canvas 1000; Carescape Canvas Smart Display

GE Healthcare Finland Oy

Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System

Life Spine, Inc.

HELIOS 785 Pico (1754V2)

Laseroptek Co., Ltd.

Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D

Fujifilm Corporaton

cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System

Roche Molecular Systems, Inc.

IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi

Shenzhen Ishine Technology Company Limited

Endo SmartCap

Medivators, Inc.

EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)

Ever Fortune.Ai, Co., Ltd.

Nova Allegro HbA1c Assay, Nova Allegro Analyzer

Nova Biomedical Corporation

Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)

Neuroelectrics Barcelona S.L.U.

SuperLine

Dentium Co., Ltd.

5 Wavelength LED Facemask (TN2508)

iSMART Developments, Ltd.

Hearing Aid Feature

Samsung Electronics Co., Ltd.

PBM Hair Therapy Cap

Dongguan Tutamen Metalwork Co., Ltd.

Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506

Shenzhen Future Electronic Co., Ltd.

Pulse Oximeter (Model C101A2, C101B1, C101A3)

Shenzhen Imdk Medical Technology Co., Ltd.