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

DZE 2024-10-10

BTI Interna 3.0 Dental Implant System UnicCa®

Applicant B.T.I. Biotechnology Institute, Sl.

K-Number K240262

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NKB 2024-10-10

GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System

Applicant Greens Surgicals Pvt. , Ltd.

K-Number K230325

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EIH 2024-10-10

Dental porcelain powder

Applicant Yilink (Tianjin) Biotechnology Co., Ltd.

K-Number K242400

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QAI 2024-10-09

SER Pen Carain MicroSystem (MP1209SP)

Applicant Su-Ko Technologies, LLC

K-Number K241355

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GEX 2024-10-09

MEDIYAG

Applicant Medicreations, LLC

K-Number K231948

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PBX 2024-10-09

eMVFit (MVF-10M)

Applicant Weero Co., Ltd.

K-Number K240991

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HWC 2024-10-09

OsteoCentric Technologies Cannulated Fasteners and Nuts

Applicant OsteoCentric Technologies

K-Number K242691

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JWY 2024-10-09

The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml.

Applicant Thermo Fisher Scientific

K-Number K242021

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QKB 2024-10-09

Limbus Contour

Applicant Limbus Ai, Inc.

K-Number K241837

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LRX 2024-10-09

CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)

Applicant Shanghai Care US Medical Product Co., Ltd.

K-Number K240095

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NHA 2024-10-09

TruAbutment DS; TruBase

Applicant Truabutment, Inc.

K-Number K241485

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HRS 2024-10-09

Clavicle and Scapula System

Applicant Auxein Medical Pvt., Ltd.

K-Number K240181

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