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

FOZ 2017-04-28

Introcan Safety 3 Closed IV Catheter

Applicant B.Braun Melsungen AG

K-Number K163358

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PEB 2017-04-28

BabyDance Fertility Lubricant

Applicant Fairhaven Health, LLC

K-Number K162319

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MQM 2017-04-28

ABL90 FLEX, ABL90 FLEX PLUS

Applicant Radiometer Medical Aps

K-Number K170882

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JAK 2017-04-28

Z-DOSE29

Applicant Zetta Medical Technologies, LLC

K-Number K170273

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PSQ 2017-04-28

CardioCel 3D

Applicant Admedus Regen Pty, Ltd.

K-Number K170951

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JWH 2017-04-28

Exactech® Truliant Line Extensions

Applicant Exactech, Inc.

K-Number K171045

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DZL 2017-04-28

Salvin Tenting Screw System

Applicant Salvin Dental Specialties

K-Number K161857

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DWJ 2017-04-28

IOB Temperature Management System

Applicant Iob Medical, Inc.

K-Number K162679

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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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