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

MQV 2024-10-18

Mg OSTEOREVIVE™, Mg OSTEOCRETE™

Applicant Bone Solutions, Inc.

K-Number K242372

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FXX 2024-10-18

Surgical Face Mask (Tie on/ Ear loops)

Applicant Xiantao Daoqi Plastic Co., Ltd.

K-Number K240916

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NHA 2024-10-18

PreXolid CAD/CAM abutments

Applicant Eclectic Co., Ltd.

K-Number K240725

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JAK 2024-10-18

Spectral CT 7500 RT

Applicant Philips Medical Systems Technologies , Ltd.

K-Number K240844

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PAH 2024-10-18

Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)

Applicant Coloplast Corp.

K-Number K242473

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GEX 2024-10-18

FREDDO

Applicant Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda

K-Number K242132

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GAP 2024-10-18

SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture

Applicant Safepath Medical, Inc.

K-Number K222944

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EBF 2024-10-18

edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK

Applicant Edelweiss Dentistry Products GmbH

K-Number K241131

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EBF 2024-10-18

Vittra APS Unique Flow

Applicant Dentscare Ltda

K-Number K232994

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MOS 2024-10-18

dS Wrist coil 8ch 1.5T

Applicant Philips Medical Systems Nederland B.V.

K-Number K243033

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OLO 2024-10-18

ROSA® Knee System

Applicant Orthosoft Inc. (d/b/a) Zimmer CAS

K-Number K242864

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BZD 2024-10-18

Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask

Applicant Sleepnet Corporation

K-Number K241830

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