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

LZA 2019-06-26

SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs

Applicant O&M Halyard, Inc.

K-Number K182851

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KGC 2019-06-26

Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set

Applicant Cook Incorporated

K-Number K182832

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GEX 2019-06-26

Phototherapy System

Applicant Shanghai Apolo Medical Technology Co., Ltd.

K-Number K190938

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NHA 2019-06-26

Elos Accurate® Customized Abutment

Applicant Elos Medtech Pinol A/S

K-Number K190299

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LLZ 2019-06-26

R2GATE

Applicant Megagen Implant Co., Ltd.

K-Number K190096

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FDX 2019-06-26

Deflectable Brush Biopsy Set

Applicant Cook Incorporated

K-Number K191485

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LNH 2019-06-26

Vantage Titan 3T, MRT-3010, V2.5

Applicant Canon Medical Systems Corporation

K-Number K191128

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OBT 2019-06-25

WishBone Guided Growth System

Applicant Wishbone Medical

K-Number K182704

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POL 2019-06-25

Trevo XP ProVue Retriever

Applicant Stryker

K-Number K190779

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QER 2019-06-25

CLARUS

Applicant Carl Zeiss Meditec, Inc.

K-Number K191194

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NXO 2019-06-25

BUHLMANN fCAL turbo

Applicant Buhlmann Laboratories AG

K-Number K190784

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DQA 2019-06-25

Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System

Applicant Taiwan Aulisa Medical Devices Technologies, Inc.

K-Number K191207

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