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

GAT 2018-03-20

ReConnex Pre-Sutured Tendon

Applicant Allosource

K-Number K170957

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JAK 2018-03-20

Philips Incisive CT

Applicant Philips Healthcare (Suzhou) Co., Ltd.

K-Number K180015

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GCJ 2018-03-20

HX Device

Applicant Human Extension , Ltd.

K-Number K173919

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ODD 2018-03-20

Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter

Applicant Wilson-Cook Medical, Inc.

K-Number K171989

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KNS 2018-03-20

Habib EndoHPB

Applicant Emcision , Ltd.

K-Number K180165

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PSZ 2018-03-20

BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit

Applicant Bd

K-Number K180438

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LNH 2018-03-20

Ingenia Elition S and Ingenia Elition X

Applicant Philips Medical Systems Nederland B.V.

K-Number K173451

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HRS 2018-03-19

PYTHON Plate Trial Instruments

Applicant Treace Medical Concepts, Inc.

K-Number K173930

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NKB 2018-03-19

CapLOX II® / TowerLOX® MIS Pedicle Screw System

Applicant Captiva Spine, Inc.

K-Number K180475

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FRC 2018-03-19

3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H

Applicant 3M Company

K-Number K173437

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NUJ 2018-03-19

Reprocessed DePuy Mitek Ablation Wand

Applicant Renovo, Inc.

K-Number K173740

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LFD 2018-03-19

Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist

Applicant Syendgen, Inc.

K-Number K173237

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