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

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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PMN 2019-06-25

Cepheid Xpert SA Nasal Complete Control Panel

Applicant Microbiologics, Inc.

K-Number K191168

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NLG 2019-06-25

Reprocessed PentaRay Nav eco High-Density Mapping Catheter

Applicant Innovative Health, LLC

K-Number K190785

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GEI 2019-06-25

Radio Frequency Ablation System

Applicant Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

K-Number K190052

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PBX 2019-06-25

Venus Bliss

Applicant Venus Concept USA, Inc.

K-Number K190743

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INI 2019-06-24

Scooter, Model: R-100

Applicant Yongkang Dingchang Industry & Trade Co., Ltd.

K-Number K182411

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MNR 2019-06-24

Maxxi Rip Sensor

Applicant Neurovirtual USA, Inc.

K-Number K171304

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FDA 2019-06-24

FUJIFILM Double Balloon Endoscope EI580BT

Applicant Fujifilm Corporation

K-Number K183032

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DQK 2019-06-24

Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle

Applicant Centerline Biomedical, Inc.

K-Number K190106

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