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

DTZ 2023-11-01

CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)

Applicant Chalice Medical , Ltd.

K-Number K231414

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MXD 2023-10-31

LINQ II Insertable Cardiac Monitor (LNQ22)

Applicant Medtronic, Inc.

K-Number K233320

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JWY 2023-10-31

Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml

Applicant Thermo Fisher Scientific

K-Number K232310

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DQY 2023-10-31

091 Balloon Guide Catheter

Applicant Eosolutions, Corp.

K-Number K231629

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DRA 2023-10-31

FlexCath Contour Steerable Sheath

Applicant Medtronic, Inc.

K-Number K232321

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KNS 2023-10-31

Speedboat Flush SB1 Instrument

Applicant Creo Medical, Ltd.

K-Number K230328

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DZE 2023-10-31

Neodent Implant System - GM Zygomatic Implant System

Applicant JJGC Indústria e Comércio de Materiais Dentários S.A.

K-Number K232099

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KWQ 2023-10-31

VICTORY Lumbar Plate System

Applicant Globus Medical, Inc.

K-Number K232318

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PQM 2023-10-31

Ultravision2 System

Applicant Alesi Surgical, Ltd.

K-Number K231238

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ITI 2023-10-31

Electric Wheelchair (Robooter E40), Model name: BBR-E40-01

Applicant Shanghai Bangbang Robotics Co., Ltd.

K-Number K231868

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CAF 2023-10-31

Hudson RCI® TurboMist Nebulizer System

Applicant Medline Industries, LP

K-Number K230602

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PQM 2023-10-31

Ultravision2 System Integrated Monopolar L-Hook (H/S)

Applicant Alesi Surgical, Ltd.

K-Number K231298

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