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 2016-06-17

CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System

Applicant Orthocare

K-Number K153374

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PNR 2016-06-17

Monoject

Applicant Covidien

K-Number K161045

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OVE 2016-06-17

Cervical Stand Alone System

Applicant Orthofix, Inc.

K-Number K161280

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DQY 2016-06-17

CenterCross Ultra Catheter

Applicant Roxwood Medical, Inc.

K-Number K160681

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DHN 2016-06-17

Image Navigator by Immuno Concepts

Applicant Immuno Concepts, N.A. , Ltd.

K-Number K160265

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FLL 2016-06-17

Withings Thermo (Model SCT01)

Applicant Withings

K-Number K160544

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PNR 2016-06-17

NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)

Applicant Neomed, Inc.

K-Number K161039

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GAT 2016-06-16

silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL

Applicant Teleflexmedical, Inc.

K-Number K153076

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JAK 2016-06-16

ECG CT Gating Device

Applicant Neocoil, LLC

K-Number K160350

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OPX 2016-06-16

Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit

Applicant The Binding Site Group , Ltd.

K-Number K160819

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LXB 2016-06-16

Sophono Bone Conduction Systems (S) Configuration and (M) Configuration

Applicant Sophono, Inc.

K-Number K153391

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MBB 2016-06-16

StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis

Applicant Biomet, Inc.

K-Number K160071

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