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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