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

NFJ 2017-11-01

IMAGEnet 6 Ophthalmic Data System

Applicant Topcon Corporation

K-Number K171370

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NUH 2017-11-01

Mytens Model: BW-TSX

Applicant Bewell Connect Corp.

K-Number K171026

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MHX 2017-11-01

Monitor B125, Monitor B105

Applicant Ge Medical Systems (China) Co., Ltd.

K-Number K171580

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MMK 2017-11-01

MAUSER PG II Sharps Container

Applicant Mauzer USA, LLC

K-Number K170513

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JOJ 2017-11-01

AN87 Dosimeter

Applicant Andersen Sterilizers, Inc.

K-Number K170439

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FPA 2017-11-01

Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set

Applicant Unomedical A/S

K-Number K162812

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OBO 2017-11-01

Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor

Applicant Heidelberg Engineering GmbH

K-Number K172649

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OOK 2017-11-01

CoolSculpting System

Applicant Zeltiq Aesthetics

K-Number K172144

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FRG 2017-11-01

Sterisheet Sterilization Wrap

Applicant Andersen Sterilizers, Inc.

K-Number K170437

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KRO 2017-11-01

GMK Hinge, GMK Revision

Applicant Medacta International S.A.

K-Number K172347

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OVE 2017-11-01

Paramount Anterior Cervical Cage System

Applicant Spine Wave, Inc.

K-Number K173175

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GAQ 2017-11-01

Surgical Stainless Steel Suture, Stainless Steel Suture

Applicant ETHICON, Inc.

K-Number K170767

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