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

LLZ 2016-12-19

Multi-Modality Tumor Tracking (MMTT) application

Applicant Philips Medical Systems Nederland B.V.

K-Number K162955

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HWC 2016-12-19

KLS Martin Cannulated Headless Screws

Applicant KLS Martin L.P.

K-Number K161259

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GXN 2016-12-17

CustomizedBone Service

Applicant Fin-Ceramica Faenza S.P.A.

K-Number K160707

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JAK 2016-12-16

Somatom Confidence ® RT Pro

Applicant Siemens Medical Solutions USA, Inc.

K-Number K162302

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MUD 2016-12-16

HyperView Hyperspectral Tissue Oxygenation Measurement System

Applicant Hypermed Imaging, Inc.

K-Number K161237

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GZB 2016-12-16

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit

Applicant Stimwave Technologies Incorporated

K-Number K162161

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MIU 2016-12-16

Chagas Detect Plus Rapid Test

Applicant InBios International, Inc.

K-Number K161947

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NBW 2016-12-16

NoCoding1 Plus Blood Glucose Monitoring System

Applicant I-Sens, Inc.

K-Number K160742

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OLI 2016-12-16

Zerona Z6 OTC

Applicant Erchonia Corporation

K-Number K162578

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IPF 2016-12-16

Xcite Clinical Station

Applicant Restorative Therapies, Inc.

K-Number K160614

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PQI 2016-12-16

CleanCisionTM Wound Retraction and Protection System

Applicant Prescient Surgical

K-Number DEN150038

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KRD 2016-12-16

LC Bead LUMI

Applicant Biocompatibles UK Limited

K-Number K162373

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