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510(k) Device Clearances

Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.

15,000 total clearances

Surgical Mask (Model: 0868F, 0866F)

Jiangxi Sanhao Medical Instruments Co.,Ltd

SONON Ultrasound Imaging System, Model: SONON300C

Healcerion Co., Ltd.

BTL-785S

BTL Industries, Inc.

Falcon HST

Compumedics Limited

ARCHITECT Toxo IgG

Abbott Laboratories

MySegmenter (v2.0.0)

Mysegmenter Technologies, Inc.

EZSensor XHD

Qpix Solutions, Inc.

Lucitone Digital Print Denture™ System

Dentsply Sirona, Inc.

Dental Zirconia Blank & Coloring Liquid

Hunan Qinghao Puzhong Technology Co., Ltd.

Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator

STERIS Corporation

Innovasis Navigation Instruments

Innovasis, Inc.

Smart Check O2 (MA0236)

Life Spark Medical, LLC

Active System; Avenue8

Caerus Corporation

CCI PACS VIEWER (PACS-US-001)

CliniComp, Intl.

SF Push-in Anchor

Surgical Fusion Technologies GmbH

Virata Spinal Fixation System

SeaSpine Orthopedics Corporation

SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option

Arineta , Ltd.

Disposable Nitrile Examination Gloves

Chifeng Huawei Medical Science&Technology Co., Ltd.

Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)

Gynesonics, Inc.

Taperloc® Complete Hip Stem

Biomet, Inc.

Medical Surgical Mask

Guangzhou Zhengkang Medical Equipment Co.,Ltd

NaturaJel™ Oral Wound Care Kit

HCS Innovation, LLC

Current Health System

Current Health , Ltd.

Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)

Ceragem Co., Ltd.

Access hsTnI

Beckman Coulter, Inc.

Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite

Ge Medical Systems, LLC

Betel Gloves Nitrile Examination Glove Powder Free

Betel Care Sdn. Bhd.

Blood Administration Sets

Baxter Healthcare Corporation

Medical Disposable Face Masks

Anqing Mayfield Medical Limited

Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System

Maquet Cardiovascular, LLC

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