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

FTM 2019-10-21

CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ)

Applicant Aziyo Biologics, Inc.

K-Number K192616

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CAH 2019-10-21

Servo Guard

Applicant Maquet Critical Care AB

K-Number K182862

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FMF 2019-10-21

BD Insulin Syringe

Applicant Becton, Dickinson and Company

K-Number K190054

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JOJ 2019-10-21

Sterilucent VH2O2 Chemical Indicators

Applicant Sterilucent, Inc.

K-Number K191999

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PQA 2019-10-21

BD MAX Vaginal Panel

Applicant Geneohm Sciences Canada, Inc. (Bd Diagnostics)

K-Number K191957

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ELC 2019-10-20

EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One

Applicant E.M.S Electro Medical Systems S.A

K-Number K190124

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MAI 2019-10-19

Arthrex SwiveLock Anchor

Applicant Arthrex, Inc.

K-Number K192532

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NKB 2019-10-19

NuVasive® Reline® 4.5-5.0 System

Applicant Nu Vasive, Incorporated

K-Number K190636

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MQV 2019-10-19

Altapore Shape

Applicant Baxter Healthcare Corporation

K-Number K191513

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FLL 2019-10-18

Infrared Forehead Thermometer (Model IR-FT)

Applicant Comper Chuangxiang (Beijing) Technology Co., Ltd.

K-Number K191668

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OHV 2019-10-18

LIPOcel

Applicant Jeisys Medical, Inc.

K-Number K181896

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MAX 2019-10-18

NuVasive Modulus XLIF Interbody System

Applicant Nu Vasive, Incorporated

K-Number K192760

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