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 2025-07-08

PathLoc Lumbar Interbody Fusion Cage System

Applicant L&K BIOMED Co., Ltd.

K-Number K251741

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JWH 2025-07-08

EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert)

Applicant Encore Medical L.P.

K-Number K251776

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SBF 2025-07-08

ExcelsiusXR

Applicant Globus Medical, Inc.

K-Number K241525

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QIH 2025-07-08

TumorSight Viz

Applicant SimBioSys, Inc.

K-Number K251766

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FED 2025-07-08

Single-use Ureteral Access Sheath

Applicant Shenzhen HugeMed Medical Technical Development Co., Ltd.

K-Number K250695

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NKB 2025-07-08

KHEIRON® Spinal Fixation System, including patient specific K-ROD

Applicant S.M.A.I.O

K-Number K251804

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DTR 2025-07-08

Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)

Applicant Spectrum Medical , Ltd.

K-Number K240908

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FMI 2025-07-08

K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)

Applicant Terumo Europe N.V.

K-Number K251447

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GEI 2025-07-08

DENSITY; DENZA; DENSITY Noir

Applicant Jeisys Medical Incorporated

K-Number K250065

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QNM 2025-07-08

Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode

Applicant Momentis Surgical , Ltd.

K-Number K251761

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LZA 2025-07-08

Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl

Applicant Encompass Industries Sdn. Bhd.

K-Number K250342

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MAX 2025-07-07

aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams

Applicant Carlsmed, Inc.

K-Number K250827

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