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

HQD 2019-01-04

BostonSight Scleral

Applicant Bostonsight

K-Number K183175

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BZD 2019-01-04

Care Orchestrator

Applicant Respironics, Inc.

K-Number K181053

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JWY 2019-01-04

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml

Applicant Thermo Fisher Scientific

K-Number K183033

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JOJ 2019-01-04

VERIFY VH202 Indicator Tape

Applicant STERIS Corporation

K-Number K183293

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OLO 2019-01-04

BridalVeil Navigated Instruments

Applicant Astura Medical

K-Number K182982

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GEX 2019-01-04

PicoLO Nd:YAG Picosecond Laser System

Applicant Laseroptek Co., Ltd.

K-Number K183392

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FRC 2019-01-03

CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack

Applicant STERIS Corporation

K-Number K183294

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OUK 2019-01-03

Cufitec Surgical Mask

Applicant Nbc Meshtec, Inc.

K-Number K182766

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FRG 2019-01-03

Safe Secure Sterilization Pouches and Rolls

Applicant Safe Secure Packing Co., Ltd.

K-Number K180139

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KCT 2019-01-03

PRO-LITE Sterilization Tray

Applicant STERIS Corporation

K-Number K183301

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MLR 2019-01-03

V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System

Applicant STERIS Corporation

K-Number K182568

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MMK 2019-01-03

Maxcon Sharps Container

Applicant Ningbo Maxcon Medical Technology Co., Ltd.

K-Number K180984

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