Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

PBY 2017-04-28

RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack)

Applicant Health Beacons, Inc.

K-Number K163667

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OXE 2017-04-28

Biodesign Staple Line Reinforcement

Applicant Cook Biotech Incorporated

K-Number K170945

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OMP 2017-04-28

VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing

Applicant Vr Medical Technologies, LLC

K-Number K162159

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OLO 2017-04-28

Smith & Nephew SURESHOT Distal Targeting System V4.0

Applicant Smith & Nephew, Inc.

K-Number K170280

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GEX 2017-04-27

U.S. Laser Worx Patriot 1 family of lasers

Applicant U.S. Laser Worx

K-Number K162334

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CBK 2017-04-27

HAMILTON-C3

Applicant Hamilton Medical AG

K-Number K161450

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KCT 2017-04-27

Instrument kits

Applicant Anthogyr

K-Number K160730

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ODC 2017-04-27

Accessory Irrigation Adapter

Applicant Wilson-Cook Medical, Inc.

K-Number K162142

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MUE 2017-04-27

RSM 2430C

Applicant DRTECH Corporation

K-Number K170930

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DZE 2017-04-27

OneQ-SL s-Clean Implant System

Applicant Dentis Co., Ltd.

K-Number K170220

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DZE 2017-04-27

Insight Dental System

Applicant Insight Dental System

K-Number K170211

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NEU 2017-04-27

Star Tissue Marker

Applicant Scion Medical Technologies, LLC

K-Number K170905

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