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

LNH 2019-06-27

LiverMultiScan (LMSv3)

Applicant Perspectum Diagnostics, Ltd.

K-Number K190017

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OCX 2019-06-27

ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector

Applicant Erbe USA, Inc.

K-Number K191438

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NHA 2019-06-26

Straumann CARES Screw-Retained Bridges and Bars

Applicant Institut Straumann AG

K-Number K190097

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PMC 2019-06-26

DigniCap Delta

Applicant Dignitana, Inc.

K-Number K191166

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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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