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

GDW 2016-03-24

iMESH Tacker

Applicant Thd Lap

K-Number K153202

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PJJ 2016-03-24

STERIZONE VP4 Sterilizer

Applicant Ts03, Inc.

K-Number K153392

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HRS 2016-03-24

Biomet Microfixation RibFix Blu Thoracic Fixation System

Applicant Biomet Microfixation

K-Number K152253

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BZE 2016-03-24

Hybernite RT

Applicant Plastiflex Group NV

K-Number K151461

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NCX 2016-03-24

Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit

Applicant Zoll Circulation, Inc.

K-Number K153226

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MAX 2016-03-24

NuVasive® Lumbar Interbody Implants

Applicant Nu Vasive, Incorporated

K-Number K153782

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DYW 2016-03-24

Exceed Tx

Applicant Great Lakes Orthodontics, Ltd.

K-Number K150702

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KGO 2016-03-24

Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating

Applicant Cardinal Health 200, Inc.

K-Number K151778

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MAX 2016-03-24

Cascadia Interbody System

Applicant K2m

K-Number K160547

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LLZ 2016-03-24

EV Insite System

Applicant Psp Corporation

K-Number K152716

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MBI 2016-03-24

TRUESPAN Meniscal Repair System

Applicant Medos International SARL

K-Number K153667

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NKB 2016-03-23

Response 5.5 Spine System

Applicant OrthoPediatrics Corp.

K-Number K160466

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