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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

Hypertension Notification Feature (HTNF)

Apple, Inc.

Surgical Gown (Sterile); Surgical Gown (Non-sterile)

Allmed Medical (Hubei) Protective Products Co., Ltd.

MBA Biotech Implant System

MBA Biotech Co., Ltd.

da Vinci SP Surgical System (SP1098)

Intuitive Surgical, Inc.

Power wheelchair

Zhejiang Zhonglei Medical Technology Co. , Ltd.

CODA™ Anterior Cervical Plate System

Pioneer Surgical Technology, Inc.

1060nm laser body slimming machine

Hebei JT Medical Co., Ltd.

Arthrex Knotless FiberTak Biceps Suture Anchor

Arthrex, Inc.

Access Toxo IgM II

Beckman Coulter, Inc.

StarFormer, TightWave

Fotona D.O.O.

BRM TOOL Screws

Brm Extremities Srl

VersiHD with GuideMe software

Nxstage Medical, Inc.

Motion InBra (YM-8801) wearable breast pump

Medela, LLC

RAYSCAN a-Expert3D

Ray Co., Ltd.

dS Sentinelle Breast 16ch 3.0T Coil

Invivo Corporation (Business Trade Name: Philips)

APEX 6

Rf Innovations, Inc.

Diode laser Treatment System (K18)

Hebei Keylaser Sci-Tech Co.,Ltd

Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)

Meditrina, Inc.

Neosoma Brain Mets

Neosoma, Inc.

ArTT Augments and Buttresses and Bone Screws

Lima Corporate S.P.A.

Insulin syringe with integrated needle DL

Dlp Medical Products, Corp.

Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)

Shenzhen Imdk Medical Technology Co., Ltd.

SKOUT® system

Iterative Scopes, Inc.

Focus HD 43 Detector

Iray Technology Taicang , Ltd.

CereFlow™ V1.2

Translational Mri, LLC

Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, u

Shenzhen Leqing Medical Instrument Co., Ltd.

Electric Wheelchair, Model: 9000N

Silver Fox Corporation Limited

Meriglu Topical Skin Adhesive

M/s. Meril Endo Surgery Private Limited.

Arterial Pressure Monitoring Set/Tray

Spectrum Vascular

Mako Total Knee Application

Mako Surgical Corp.

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