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

KGN 2022-08-18

Miro3D Wound Matrix

Applicant Reprise Biomedical, Inc.

K-Number K221520

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JSM 2022-08-18

iClean Viral Transport System (VTM-RT kit)

Applicant Huachenyang (Shenzhen) Technology Co. , Ltd.

K-Number K212856

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NPK 2022-08-18

Bio-MEM Ti Reinforced Membrane

Applicant B&Medi Co., Ltd.

K-Number K210797

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GEH 2022-08-18

truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184

Applicant STERIS Corporation

K-Number K222272

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MAX 2022-08-17

TDM Lumbar Interbody Fusion Cage System

Applicant Tdm Co., Ltd.

K-Number K221844

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FXX 2022-08-17

Surgical Face Mask (HNFM0103)

Applicant Shanghai Hua EN Industrial Co, Ltd.

K-Number K221838

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LLZ 2022-08-17

WebCeph

Applicant Assemblecircle Corp.

K-Number K220903

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LZO 2022-08-17

implaFit® hip stems

Applicant Implantcast GmbH

K-Number K210678

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HAW 2022-08-17

Disposable Brain Biopsy Needle 2.0

Applicant PAJUNK GmbH Medizintechnologie

K-Number K220897

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FXX 2022-08-17

Cross Protection ResQ300 Plus Surgical Face Mask

Applicant Cross Protection (M) Sdn Bhd

K-Number K212273

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FMF 2022-08-17

Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle

Applicant Shandong Zhushi Pharmaceutical Group Co., Ltd.

K-Number K212033

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KOI 2022-08-17

Tetragraph Neuromuscular Transmission Monitor

Applicant Senzime AB

K-Number K220530

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