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

FDT 2019-11-15

Pentax Medical Video Duodenoscope ED34-i10T2

Applicant Pentax of America, Inc.

K-Number K192245

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IZL 2019-11-15

Soltus 500

Applicant Sedecal., Sa.

K-Number K192936

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JXG 2019-11-15

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit

Applicant Irras USA, Ltd.

K-Number K192289

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PFO 2019-11-15

Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments

Applicant Cochlear Americas

K-Number K191921

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MYC 2019-11-15

DRSplus

Applicant Centervue S.P.A.

K-Number K192113

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HQF 2019-11-15

Ophthalmic Yag Laser System YC-200

Applicant Nidek Co., Ltd.

K-Number K192045

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PIF 2019-11-15

Gabriel Feeding Tube with Balloon, and EnFit Connector

Applicant Syncro Medical Innovations, Inc.

K-Number K191784

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QBK 2019-11-15

Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA

Applicant Immunalysis Corporation

K-Number K190397

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OWN 2019-11-15

SPY Portable Handheld Imaging (SPY-PHI) System

Applicant Novadaq Technologies Ulc. (Now A Part of Stryker)

K-Number K192174

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DZE 2019-11-15

EM SA Implant System

Applicant Hiossen, Inc.

K-Number K191201

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HSB 2019-11-14

EBA One Nailing System

Applicant Citieffe S.R.L.

K-Number K183666

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JWY 2019-11-14

MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL)

Applicant Beckman Coulter, Inc.

K-Number K192355

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