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

NHA 2023-10-17

Dynamic TiBase

Applicant Talladium España, SL

K-Number K232151

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FBN 2023-10-17

Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)

Applicant Shanghai AnQing Medical Instrument Co., Ltd.

K-Number K231105

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ODP 2023-10-17

HAtetracell-C Titanium Cervical IBF System

Applicant Innovasis, Inc.

K-Number K231899

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MHX 2023-10-17

Infinity CentralStation Wide, Infinity M300, Infinity M300+

Applicant Draeger Medical Systems, Inc.

K-Number K231477

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QDD 2023-10-17

Lumen 155-SF

Applicant Intricon Corporation

K-Number K223911

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OUR 2023-10-17

TransLoc 3D

Applicant Foundation Fusion Solutions, LLC (Dba Cornerloc)

K-Number K232878

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GEI 2023-10-17

Legend X Platform

Applicant Pollogen, Ltd.

K-Number K232903

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DSB 2023-10-17

SOZO Pro

Applicant ImpediMed Limited

K-Number K232089

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FXY 2023-10-17

ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)

Applicant Thi Total Healthcare Innovation GmbH

K-Number K222214

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DZE 2023-10-16

Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL

Applicant Anthogyr

K-Number K230104

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ODC 2023-10-16

ANDORATE® Valve Kit

Applicant Ga Health Company Limited

K-Number K232118

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HGX 2023-10-16

Willow Generation 3 Breast Pump

Applicant Willow Innovations, Inc.

K-Number K230570

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