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

QAU 2024-10-22

PuraStat

Applicant 3-D Matrix Europe SAS

K-Number K242250

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OWB 2024-10-22

ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)

Applicant Siemens Medical Solutions USA, Inc.

K-Number K241572

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OCV 2024-10-22

KARL STORZ Holders

Applicant Karl Storz Endoscopy America, Inc.

K-Number K240506

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FMF 2024-10-22

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

Applicant Sol-Millennium Medical, Inc.

K-Number K242099

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NHA 2024-10-21

Dynamic TiBase; TRI Screws

Applicant Talladium España, SL

K-Number K241170

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FRO 2024-10-21

Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch

Applicant Speciality Fibres and Materials, Ltd.

K-Number K222740

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SCW 2024-10-21

Digital Prism Correction Feature (DPCF)

Applicant Apple, Inc.

K-Number K242058

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JDI 2024-10-21

Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems

Applicant Smith & Nephew, Inc.

K-Number K240783

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QYX 2024-10-21

Zio AT® device (A100A1001)

Applicant iRhythm Technologies, Inc.

K-Number K240029

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QNM 2024-10-21

Anovo Surgical System (Model 6Ne)

Applicant Momentis Surgical , Ltd.

K-Number K242157

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GEI 2024-10-21

PhotonBlade 3; PhotonBlade 3 Smoke Evacuation

Applicant Stryker Instruments

K-Number K242266

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HRS 2024-10-21

Arthrex VAL and VAL KreuLock™ Compression Screw System

Applicant Arthrex, Inc.

K-Number K242554

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