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

PLB 2024-07-22

NAVOYCDS

Applicant Algodx AB

K-Number K240558

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NUH 2024-07-22

Transcutaneous Electrical Nerve Stimulator (K6106)

Applicant Shenzhen Yicai Health Technology Co., Ltd.

K-Number K241119

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KLE 2024-07-22

K-Bond Universal

Applicant Spident Co., Ltd.

K-Number K241445

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ITI 2024-07-22

Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric Wheelchair (Robooter E60) (BBR-E60-03); Electric Wheelchair (Robooter E60) (BBR-E60-04); Electric Wheelchair (Robooter E60) (BBR-E60-05); Electric Wheelchair (Robooter E60) (BBR-E60-06); Electric Wheelchair (Robooter E60) (BBR-E60-07); Electric Wheelchair (Robooter E60) (BBR-E60-08)

Applicant Shanghai Bangbang Robotics Co., Ltd.

K-Number K240339

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LNH 2024-07-22

neo315

Applicant Neoscan Solution GmbH

K-Number K231133

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NGX 2024-07-21

PTG-05

Applicant Zimmer Medizinsysteme GmbH

K-Number K240347

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MBI 2024-07-19

Suture Button Repair System

Applicant Skeletal Dynamics, Inc.

K-Number K240835

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FRO 2024-07-19

coactiv+ Antimicrobial Wound Gel

Applicant Kane Biotech, Inc.

K-Number K241809

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NAY 2024-07-19

Senhance Surgical System

Applicant Asensus Surgical, Inc.

K-Number K233866

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NEY 2024-07-19

IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)

Applicant Varian Medical Systems, Inc.

K-Number K240480

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NUH 2024-07-19

Wireless TENS & EMS (Model SM9110,SM9113,SM9116)

Applicant Chongqing Rob Linka Science and Technology Co., Ltd.

K-Number K233067

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JKA 2024-07-19

VACUETTE® QUICKSHIELD Complete (Plus)

Applicant Greiner Bio-One North America, Inc.

K-Number K233979

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