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

ELC 2023-07-14

Proxeo ULTRA (PB-510, PB-520 and PB-530)

Applicant W&H Dentalwerk Buermoss GmbH

K-Number K223173

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LLZ 2023-07-14

JiveX (Model Number / Release: 5.4)

Applicant Visus Health IT GmbH

K-Number K231041

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DQY 2023-07-13

Micro Rx

Applicant Imds Operations B.V.

K-Number K223728

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JAK 2023-07-13

Spine Auto Views

Applicant GE Medical Systems SCS

K-Number K223424

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JAD 2023-07-13

X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)

Applicant Xstrahl, Ltd.

K-Number K230611

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NEU 2023-07-13

HydroMARK Plus Breast Biopsy Site Marker

Applicant Devicor Medical Products, Inc.

K-Number K221961

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MAX 2023-07-13

Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System

Applicant Alphatec Spine, Inc.

K-Number K231438

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LLZ 2023-07-13

Chondral Quant

Applicant Siemens Medical Soultions USA, Inc.

K-Number K231351

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QLQ 2023-07-13

activL® Next Generation Instrumentation

Applicant Aesculap Implants Systems, LLC

K-Number K231769

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MNS 2023-07-13

ReddyPort Elbow

Applicant Smd Manufacturing, LLC

K-Number K231064

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JAK 2023-07-13

Open Rib

Applicant Canon Medical Informatics, Inc.

K-Number K223261

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LNH 2023-07-13

ECHELON Synergy MRI system

Applicant Fujifilm Healthcare Corporation

K-Number K223426

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