Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

OUR 2024-11-21

TiLink-P Joint Fusion System

Applicant SurGenTec, LLC

K-Number K242414

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PBX 2024-11-21

MIRARI® Cold Plasma System ( GV-M2-01)

Applicant General Vibronics, Inc.

K-Number K242553

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LLZ 2024-11-21

Jazz Classic

Applicant Jazz Imaging

K-Number K241495

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MBP 2024-11-21

PliaFX Flo

Applicant Lifenet Health

K-Number K242799

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KRO 2024-11-21

ATTUNE Revision Hinge Knee

Applicant Depuy Ireland UC

K-Number K242871

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HRS 2024-11-21

GMReis Ankle Plating System

Applicant GM Dos Reis Industria e Comercio Ltda.

K-Number K242998

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CBF 2024-11-21

FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber

Applicant Fink Engineering Pty, Ltd.

K-Number K240569

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DQA 2024-11-21

Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH

Applicant Shenzhen Smallsignal Technology Co., Ltd.

K-Number K232520

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MQB 2024-11-21

SKR 3000

Applicant Konica Minolta, Inc.

K-Number K241319

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EZD 2024-11-21

Luja Coude

Applicant Coloplast Corp.

K-Number K241210

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HRS 2024-11-21

Versalock Mini and Micro Plating System

Applicant GM Dos Reis Industria e Comercio Ltda.

K-Number K242596

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JAK 2024-11-21

Gating Reflector Block

Applicant Varian Medical Systems, Inc.

K-Number K242874

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