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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

Lifemotion Disposable Membrane Oxygenator

Lifemotion Medical Technology Co., Ltd.

MI View&GO

Siemens Medical Solutions USA, Inc.

ToxiSeal™ Vial Adaptor with External Flip Balloon

Epic Medical Pte. , Ltd.

Genius AI Detection 2.0

Hologic, Inc.

Pro-Tx Endorectal Balloon (PROT-25)

Dxtx Medical, Inc.

Precice Intramedullary Limb Lengthening System

Nuvasive Specialized Orthopedics, Inc.

Chartis Precision Catheter

Pulmonx Corporation

Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series T

Covidien

AirTom

Bilab

Kangbeier Child Surgical Mask

Xinxiang Kangbeier Medical Technology Co., Ltd.

XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conv

Stryker Spine

VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P

Vinno Technology (Suzhou) Co.,Ltd

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Rmkh Glove (Cambodia) Co., Ltd.

BriefCase-Quantification

Aidoc Medical , Ltd.

Varios Combi Pro2

Nakanishi, Inc.

Diosculpt

Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd

Myflon Surgical Mask Level 3

Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi

GMReis Suture Anchors

GM Dos Reis Industria e Comercio Ltda.

CORTRAK* 2 Enteral Access System (20-0950)

Avanos Medical, Inc.

Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle

Sol-Millennium Medical, Inc.

Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Con

Pegavision Corporation

MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A

Siemens Medical Solutions USA, Inc.

Contour ProtégéAI

Mim Software, Inc.

Radiant Renewal Skincare Wand (HD-15, HD-15A)

Shenzhen Kaiyan Medical Equipment Co., Ltd.

JDZygoma dental implants

Jdentalcare Srl

Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microte

Microtek Medical, LLC

Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)

The Magstim Company Limited

ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Staple

Ethicon Endo-Surgery, LLC

VersaWrap

Alafair Biosciences, Inc.

AI Segmentation

Varian Medical Systems, Inc.

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