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

EOQ 2019-01-04

GlideScope BFlex Single-Use Bronchoscope System

Applicant Verathon Medical (Canada) Ulc

K-Number K183256

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MBI 2019-01-04

CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver

Applicant Conmed Corporation

K-Number K182621

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DZE 2019-01-04

Straumann PURE Ceramic Implant System

Applicant Institut Straumann AG

K-Number K180477

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JOJ 2019-01-04

Celerity HP Chemical Indicator (CI)

Applicant Steris Corporations

K-Number K183295

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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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