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

HRS 2022-10-18

EVOS Wrist Spanning Plate

Applicant Smith & Nephew, Inc.

K-Number K213123

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QIH 2022-10-18

Spine CAMP

Applicant Medical Metrics, Inc.

K-Number K221632

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DPS 2022-10-18

MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System

Applicant Ge Medical Systems Information Technologies, Inc.

K-Number K221321

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KWQ 2022-10-18

FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM & BALTEUM-ONE Lumbar Plate System

Applicant Dio Medical Corporation

K-Number K222572

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MSY 2022-10-18

E-Z Chek Chlorine Residual Test Strips (K100-0101B)

Applicant Reprocessing Products Corporation (Rpc)

K-Number K222167

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MAX 2022-10-18

DualXSLIM(R) T/PLIF

Applicant Amplify Surgical, Inc.

K-Number K222203

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PNO 2022-10-18

XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter

Applicant Transit Scientific, LLC

K-Number K221986

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QRG 2022-10-18

ScanNav Anatomy Peripheral Nerve Block

Applicant Intelligent Ultrasound Limited

K-Number DEN220024

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HRX 2022-10-18

TELIGEN System

Applicant Medos International SARL

K-Number K213978

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CGA 2022-10-18

Nova Primary Glucose Analyzer System

Applicant Nova Biomedical Corporation

K-Number K203549

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QRL 2022-10-18

TRUEdraw Lancing Device, Mini Lancing Device

Applicant Trividia Health

K-Number K221072

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FRO 2022-10-18

MEBO Wound Dressing

Applicant Mebo Life Science, Inc.

K-Number K222657

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