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

LPL 2018-02-22

Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens

Applicant Menicon Co, Ltd.

K-Number K180004

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FLE 2018-02-22

Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)

Applicant STERIS Corporation

K-Number K173490

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PLV 2018-02-22

Neocis Guidance System (NGS) with Chairside Splint

Applicant Neocis, Inc.

K-Number K173402

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KWL 2018-02-22

Remedy Acetabular Cup

Applicant Osteoremedies, LLC

K-Number K173967

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MQV 2018-02-22

SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty

Applicant Hans Biomed Corporation

K-Number K171568

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DRC 2018-02-21

TSN Transseptal Needle

Applicant Pressure Products Medical Device Manufacturing, LLC

K-Number K172950

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EOQ 2018-02-21

Captura Disposable Bronchoscope Biopsy Forceps

Applicant Wilson-Cook Medical, Inc.

K-Number K163377

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KRB 2018-02-21

PiCCO Catheter

Applicant Pulsion Medical Systems SE

K-Number K171620

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GEX 2018-02-21

DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)

Applicant El.En Electronic Engineering Spa

K-Number K180193

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FRC 2018-02-21

CELERITY 20 Steam Process Challenge Device for Gravity Cycles

Applicant STERIS Corporation

K-Number K173629

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FRC 2018-02-21

Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles

Applicant STERIS Corporation

K-Number K173626

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NUJ 2018-02-21

Reprocessed ArthroCare ENT Coblator

Applicant Renovo, Inc.

K-Number K172647

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