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

JAQ 2017-08-31

Kelowna GYN and Crook Prostate Templates

Applicant Varian Medical Systems, Inc.

K-Number K162533

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MQL 2017-08-31

Arctic Sperm Cryopreservation Medium

Applicant Irvine Scientific Sales Co., Inc.

K-Number K171224

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JXG 2017-08-31

SureFlo EVD Catheter

Applicant Arkis Biosciences, Inc.

K-Number K170599

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KLE 2017-08-31

SHOFU MZ Primer Plus

Applicant Shofu Dental Corporation

K-Number K172106

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DZE 2017-08-31

Internal Octa Implant System

Applicant Ebi, Inc.

K-Number K170031

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JDB 2017-08-31

Latitude EV Total Elbow Arthroplasty

Applicant Tornier, Inc.

K-Number K171010

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NKB 2017-08-31

Additional VIPER PRIME™ screws with fenestrations

Applicant Medos International SARL

K-Number K171570

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PGN 2017-08-31

MAGEC® System

Applicant Nuvasive Specialized Orthopedics, Incorporated

K-Number K171791

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LIT 2017-08-31

Pirouette High Pressure (HP)

Applicant Arravasc, Ltd.

K-Number K172033

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EBW 2017-08-31

NLZ Motor System

Applicant Nakanishi, Inc.

K-Number K163402

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FLE 2017-08-31

Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer

Applicant Midmark Corporation

K-Number K163337

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FGB 2017-08-31

Medical Video Endoscope System

Applicant Zhuhai Pusen Medical Technology Co., Ltd.

K-Number K172098

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