Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

LPL 2026-05-21

Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses

Applicant Pegavision Corporation

K-Number K253352

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KPS 2026-05-21

Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family

Applicant Siemens Medical Solutions USA, Inc.

K-Number K261315

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FMF 2026-05-21

Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)

Applicant Hlb Lifescience Co., Ltd.

K-Number K253112

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NUC 2026-05-21

pjur NATURE Touch, 100 ml

Applicant Pjur Group Luxembourg S.A.

K-Number K260068

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QME 2026-05-21

PanopticAI Vital Signs (1.6.1-22)

Applicant PanopticAI Technologies Limited

K-Number K260066

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OLO 2026-05-21

ROSA® Shoulder System

Applicant Orthosoft Inc. (d/b/a) Zimmer CAS

K-Number K260582

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GEX 2026-05-21

Boston 2910 (Boston 2910)

Applicant Boston Aesthetics, Inc.

K-Number K253245

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KNS 2026-05-21

Sphincterotome

Applicant Taewoong Medical Co., Ltd.

K-Number K260962

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QIH 2026-05-21

MSK Go

Applicant Smart Alfa Teknoloji San. Ve Tic. A.S.

K-Number K260234

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OHT 2026-05-21

Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)

Applicant Shenzhen Ulike Smart Electronics Co., Ltd.

K-Number K261325

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FTL 2026-05-21

ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)

Applicant Sofradim Production

K-Number K253956

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BSZ 2026-05-21

Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)

Applicant Drägerwerk AG Co. Kgaa

K-Number K252746

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