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

DZE 2018-02-10

TAV Medical Dental Implants System

Applicant Tav Medical , Ltd.

K-Number K170131

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OWB 2018-02-09

CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System

Applicant Omega Medical Imaging, LLC

K-Number K171755

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CAP 2018-02-09

NAPA LP-15 Airway Pressure Monitor

Applicant Drw Medical, LLC

K-Number K172284

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FED 2018-02-09

ORISE Tissue Retractor System

Applicant Boston Scientific

K-Number K173400

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HEB 2018-02-09

Tosama Biobased Applicator Tube Menstrual Tampon

Applicant Tosama, D.O.O.

K-Number K172504

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LON 2018-02-09

BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL)

Applicant Becton, Dickinson and Company

K-Number K173523

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EZL 2018-02-09

Kohli Urinary Drainage Catheter

Applicant Nellie Medical, LLC

K-Number K172422

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GCJ 2018-02-09

Ergonomic Handle

Applicant Symmetry Surgical, Inc.

K-Number K173272

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NXC 2018-02-09

Blue Sky Bio Aligner

Applicant Blue Sky Bio, LLC

K-Number K180107

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JOJ 2018-02-09

VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label

Applicant STERIS Corporation

K-Number K172746

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NHA 2018-02-09

Southern Implants PEEK Abutments

Applicant Southern Implants (Pty), Ltd.

K-Number K172160

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JAQ 2018-02-09

Standard Catheter Set

Applicant Varian Medical Systems, Inc.

K-Number K171631

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