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

MRW 2023-12-19

PMT Facet Fixation System, Lumbar (PMT FFS-LX)

Applicant Providence Medical Technology, Inc.

K-Number K230840

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FLE 2023-12-19

PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)

Applicant Primus Sterilizer Company, LLC

K-Number K233132

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MHX 2023-12-19

IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)

Applicant Philips Medizin Systeme Boeblingen GmbH

K-Number K231671

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DSY 2023-12-19

GORE® ACUSEAL Vascular Graft

Applicant W. L. Gore & Associates, Inc.

K-Number K233551

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NHA 2023-12-19

Angled Abutment

Applicant Arum Dentistry Co., Ltd.

K-Number K232560

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BZH 2023-12-19

TD-7301 Peak Flow meter

Applicant Gostar Co., Ltd.

K-Number K222810

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DZE 2023-12-18

S-Plant Dental Implant System

Applicant Idis Co., Ltd.

K-Number K231429

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HTN 2023-12-18

CC-Clip® Implant System

Applicant Cc-Instruments, Inc.

K-Number K232780

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MMI 2023-12-18

Access hsTnI

Applicant Beckman Coulter, Inc.

K-Number K222881

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GCJ 2023-12-18

CuratOR EX3242-FD

Applicant Eizo Corporation

K-Number K231066

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QIH 2023-12-18

iQ-solutions

Applicant Sydney Neuroimaging Analysis Centre Pty, Ltd.

K-Number K231929

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EOQ 2023-12-18

Ion Endoluminal System (IF1000)

Applicant Intuitive Surgical, Inc.

K-Number K232984

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