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

MAX 2018-02-12

Zyston Strut Open Titanium Spacer System

Applicant Zimmer Biomet Spine, Inc.

K-Number K171495

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OVD 2018-02-12

CASCADIA Interbody System

Applicant K2m

K-Number K172941

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OCW 2018-02-12

MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle

Applicant Teleflexmedical, Inc.

K-Number K172775

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LYZ 2018-02-12

Vinyl Patient Examination Glove (Yellow)

Applicant Yurun Glove Co., Ltd.

K-Number K173561

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FRC 2018-02-12

CELERITY 20 Steam Incubator

Applicant STERIS Corporation

K-Number K173670

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PWI 2018-02-12

Digitex Delivery Device

Applicant Coloplast A/S

K-Number K173527

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FRC 2018-02-12

CELERITY 20 Steam Biological Indicator

Applicant STERIS Corporation

K-Number K173634

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DQX 2018-02-12

ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter

Applicant Asahi Intecc Co., Ltd.

K-Number K171933

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LLZ 2018-02-12

SuRgical Planner (SRP)

Applicant Surgical Theater, LLC

K-Number K170793

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OHT 2018-02-12

Home Use Hair Removal Device/T1, T2, T3

Applicant Shenzhen Mareal Tech Co., Ltd.

K-Number K172883

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HWC 2018-02-12

MotoBAND CP Implant System

Applicant Crossroads Extremity Systems, LLC

K-Number K173710

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IPF 2018-02-11

geko T-2 and geko Plus R-2

Applicant Firstkind, Ltd.

K-Number K180082

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