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

DQX 2024-05-24

PacePro Wire

Applicant Opsens, Inc.

K-Number K240864

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FRO 2024-05-24

ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC

Applicant Foshan United Medical Technologies, Ltd.

K-Number K233111

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DZE 2024-05-24

8plant Implant System

Applicant Hoowon Edi Co., Ltd.

K-Number K231426

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NHA 2024-05-24

KATANA Zirconia ONE For IMPLANT

Applicant Kuraray Noritake Dental, Inc.

K-Number K233285

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KPS 2024-05-24

SET-5002

Applicant Shimadzu Corporation Medical Systems Division

K-Number K240827

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KHJ 2024-05-24

Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)

Applicant Cook Biotech Incorporated

K-Number K232646

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KWQ 2024-05-24

Wolff's Law Anterior Cervical Plate System

Applicant Spinal Simplicity, LLC

K-Number K240592

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OBR 2024-05-24

Anti Grinding Guard

Applicant Xiamen Yizhou Imp. & Exp. Co., Ltd.

K-Number K240810

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OMP 2024-05-24

Renasys Edge

Applicant Smith & Nephew Medical, Ltd.

K-Number K231939

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QFG 2024-05-24

DEKA ACE Pump System

Applicant Deka Research and Development

K-Number K241178

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QIH 2024-05-24

LVivo IQS

Applicant Dia Imaging Analysis, Ltd.

K-Number K240769

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QJI 2024-05-23

CamAPS FX

Applicant Camdiab , Ltd.

K-Number K232603

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