Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

JAK 2022-08-11

Medical image processing software

Applicant Hangzhou Deepwise & League of PHD Technology Co., Ltd.

K-Number K220910

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QKQ 2022-08-11

Novo

Applicant PathAI, Inc.

K-Number K212361

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MHX 2022-08-11

Patient Monitor: RespArray

Applicant Edan Instruments, Inc.

K-Number K220308

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PLL 2022-08-11

LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)

Applicant Ovesco Endoscopy AG

K-Number K221385

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NEY 2022-08-11

NEUWAVE Microwave Ablation System and Accessories

Applicant Neuwave Medical, Inc.

K-Number K220472

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DZJ 2022-08-11

OMF ASP System

Applicant Vha Dean

K-Number K220648

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MEH 2022-08-11

Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem

Applicant Stryker

K-Number K220731

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EBI 2022-08-11

TERA HARZ DENTURE

Applicant Graphy, Inc.

K-Number K222414

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MBI 2022-08-11

Arthrex Knotless FiberTak Biceps Suture Anchor

Applicant Arthrex, Inc.

K-Number K222161

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FMF 2022-08-11

InstaFill Graft Delivery System, SIGNIFY Bioactive

Applicant Globus Medical, Inc.

K-Number K221737

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JAK 2022-08-11

AI-Rad Companion (Pulmonary)

Applicant Siemens Healthcare GmbH

K-Number K213713

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MQN 2022-08-11

KLS Martin IPS Distraction

Applicant KLS Martin L.P.

K-Number K220050

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