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

GCJ 2023-06-08

Disposable Laparoscopic Trocar

Applicant Changzhou Ankang Medical Instruments Co., Ltd.

K-Number K231042

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IYE 2023-06-08

SIDDHARTH-II;IMPACT

Applicant Panacea Medical Technologies Pvt. , Ltd.

K-Number K222762

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OAB 2023-06-08

Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe

Applicant Zhejiang Curaway Medical Technology Co., Ltd.

K-Number K222001

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QAQ 2023-06-08

Acumen Hypotension Prediction Index (HPI) Algorithm

Applicant Edwards Lifesciences, LLC

K-Number K230057

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PBX 2023-06-08

Zionic Aesthetic

Applicant Termosalud

K-Number K230659

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LCJ 2023-06-08

AlloX2 Pro Tissue Expanders

Applicant Sientra, Inc.

K-Number K214124

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DQK 2023-06-08

AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub

Applicant Philips Medical Systems Nederland B.V.

K-Number K223918

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DZE 2023-06-08

SNUCONE Tissue Level Implant System

Applicant Snucone Co., Ltd.

K-Number K222792

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PTI 2023-06-08

Promisemed Safety Huber Needle

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K230715

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MBI 2023-06-07

Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)

Applicant Suzhou Endophix Co., Ltd.

K-Number K231002

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OUR 2023-06-07

TiLink-L SI Joint Fusion System

Applicant SurGenTec, LLC

K-Number K230446

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FLL 2023-06-07

Infrared Thermometer

Applicant Alicn Medical Shenzhen, Inc.

K-Number K222248

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