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

KRO 2021-06-30

LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE

Applicant Waldemar Link GmbH & Co. KG

K-Number K211768

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DWF 2021-06-30

Quantum Perfusion Arterial Cannula Graft

Applicant Qura S.R.L

K-Number K203057

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CCJ 2021-06-30

Pivot Breath Sensor

Applicant Carrot, Inc.

K-Number K201206

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MAX 2021-06-30

aprevo Transforaminal IBF

Applicant Carlsmed, Inc.

K-Number K210542

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HBE 2021-06-30

Stryker iBur hubs and cutting accessories

Applicant Stryker Corporation

K-Number K210377

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DXH 2021-06-30

KardiaMobile 6L

Applicant AliveCor, Inc.

K-Number K210753

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GCJ 2021-06-30

Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0

Applicant Fujifilm Corporaton

K-Number K203717

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HRS 2021-06-29

Smith & Nephew Plates and Screws

Applicant Smith & Nephew, Inc.

K-Number K210837

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LNH 2021-06-29

STAGE

Applicant Spintech, Inc.

K-Number K210843

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PGY 2021-06-29

12MP Color Digital Mammography LCD Monitor CL-S1200

Applicant Jvckenwood Corporation

K-Number K203733

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FXX 2021-06-29

Nordiwell Surprotect Face Mask

Applicant Changzhou Combat Protective Equipment Co., Ltd.

K-Number K210445

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KNT 2021-06-29

Standard Bougie, 38 Fr.

Applicant Standard Bariatrics

K-Number K210437

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