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

OWB 2016-01-12

INFX-8000V, V6.20

Applicant Toshibamedical Systems Corporation

K-Number K152696

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BZG 2016-01-12

IQSense Flow Sensor Mouthpiece

Applicant Sdi Diagnostics, Inc.

K-Number K150515

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OWB 2016-01-12

Cios Connect

Applicant Siemens Medical Solutions USA, Inc.

K-Number K153147

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PGY 2016-01-12

3MP Color LCD Monitor, RadiForce RX350

Applicant Eizo Corporation

K-Number K153354

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KPS 2016-01-12

Biograph Horizon PET/CT

Applicant Siemens Medical Solutions USA, Inc.

K-Number K152880

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FAD 2016-01-11

Universa Soft Ureteral Stents and Stent Sets

Applicant Cook Incorporated

K-Number K151051

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JPA 2016-01-11

Sysmex Automated Blood Coagulation Analyzer CS-5100

Applicant Siemens Healthcare Diagnostic Products GmbH

K-Number K150678

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NUC 2016-01-11

K-Y Marilyn Pleasure Gel

Applicant Reckitt Benckiser, LLC

K-Number K151884

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DZE 2016-01-11

PURE Ceramic Implants

Applicant Straumann USA

K-Number K151328

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DYB 2016-01-11

Fortress Introducer Sheath SYstem

Applicant Contract Medical International, GmbH

K-Number K153197

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DQY 2016-01-08

LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM

Applicant Tni Manufacturing, Inc.

K-Number K152876

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ERL 2016-01-08

Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces

Applicant Karl Storz Endoscopy America, Inc.

K-Number K150969

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