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

MAX 2024-09-11

Signus Tetris St; Signus Tetris R St

Applicant Signus Medizintechnik GmbH

K-Number K241438

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MAI 2024-09-11

HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors

Applicant Depuy Mitek

K-Number K241010

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HGX 2024-09-11

Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)

Applicant Huizhou Lvb Maternal and Infant Supplies Co., Ltd.

K-Number K241004

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OWQ 2024-09-10

Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)

Applicant Surgical Instrument Service and Savings, Inc.

K-Number K234064

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NAY 2024-09-10

8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads

Applicant Intuitive Surgical, Inc.

K-Number K241638

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DTK 2024-09-10

Option ELITE Vena Cava Filter System (352506070E 352506100E)

Applicant Argon Medical Devices, Inc.

K-Number K242612

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KWS 2024-09-10

Tornier Humeral Reconstruction System (Tornier HRS)

Applicant Stryker Corporation (Tornier, Inc.)

K-Number K241609

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INI 2024-09-10

Mobility Scooter

Applicant Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

K-Number K240990

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QIH 2024-09-10

LumiNE US; Lumi

Applicant Augmedit B.V.

K-Number K240094

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FYA 2024-09-10

ProPel SG3 Surgical Gown

Applicant Standard Textile Co., Inc.

K-Number K241214

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GEX 2024-09-09

FoLix

Applicant Lumenis Be, Ltd.

K-Number K242349

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QIH 2024-09-09

ADAS 3D

Applicant Adas3D Medical S.L.

K-Number K240791

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