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

CBK 2024-11-13

RESPOND(R) Ventilator

Applicant Corvent Medical, Inc.

K-Number K241135

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EIH 2024-11-13

Dental Glass Ceramics Blocks (HT, LT, MT)

Applicant Hunan Vsmile Biotechnology Co., Ltd.

K-Number K242407

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OLK 2024-11-13

Nonin OTC Pulse Oximeter Model 3250

Applicant Nonin Medical, Inc.

K-Number K211498

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EFB 2024-11-13

Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)

Applicant Guangdong Jinme Medical Technology Co., Ltd.

K-Number K240337

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NKB 2024-11-13

MediRod Pedicle Screw System

Applicant Cmf Medicon Surgical, Inc.

K-Number K242764

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FRO 2024-11-13

LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K-Number K242856

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OPP 2024-11-13

CeQur Simplicity On-Demand Insulin Delivery System

Applicant Cequr SA

K-Number K243273

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ITI 2024-11-12

Electric wheelchair (KR-8807)

Applicant Zhejiang Kairui Medical Device Co., Ltd.

K-Number K242791

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CCK 2024-11-12

AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask

Applicant Vyaire Medical, Inc.

K-Number K230915

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SDC 2024-11-12

VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator

Applicant Steris

K-Number DEN230085

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MQB 2024-11-12

PRORAD X-Ray Flat Panel Detector with DROC

Applicant Prognosys Medical Systems Private Limited

K-Number K240771

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FED 2024-11-12

Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)

Applicant Coloplast Corp.

K-Number K242173

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