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

DPS 2017-02-15

PC ECG

Applicant Edan Instruments, Inc.

K-Number K160876

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PNR 2017-02-15

Medela Low Dose Enteral Syringe

Applicant Medela, Inc.

K-Number K161811

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MXD 2017-02-14

Reveal LINQ Insertable Cardiac Monitor

Applicant Medtronic, Inc.

K-Number K163460

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OZN 2017-02-14

Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack

Applicant Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC

K-Number K163085

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NKB 2017-02-14

Erisma® LP Spinal Fixation System

Applicant Clariance, Sas

K-Number K170163

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IPF 2017-02-14

FA100 SCCD (Sequential Continuous Contraction Device)

Applicant Flowaid Medical Technologies, Corp

K-Number K162987

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GEH 2017-02-14

ClariFix Device

Applicant Arrinex, Inc.

K-Number K162608

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LLZ 2017-02-14

SIS Software

Applicant Surgical Information Sciences, Inc.

K-Number K162830

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GEI 2017-02-14

ENSEAL X1 Large Jaw Tissue Sealer

Applicant Ethicon Endo-Surgery, LLC

K-Number K163548

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ILY 2017-02-14

Bashan TDP Heat Lamp

Applicant Chogqing Yuhe Medical Instruments Co., Ltd.

K-Number K162590

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OUO 2017-02-14

SIGNA PET/MR

Applicant Ge Medical Systems, LLC

K-Number K163619

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LLZ 2017-02-14

syngo Application Software

Applicant Siemens Medical Solution USA, Inc.

K-Number K163285

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