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

QME 2026-05-21

PanopticAI Vital Signs (1.6.1-22)

Applicant PanopticAI Technologies Limited

K-Number K260066

View Details →

OLO 2026-05-21

ROSA® Shoulder System

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

K-Number K260582

View Details →

GEX 2026-05-21

Boston 2910 (Boston 2910)

Applicant Boston Aesthetics, Inc.

K-Number K253245

View Details →

KNS 2026-05-21

Sphincterotome

Applicant Taewoong Medical Co., Ltd.

K-Number K260962

View Details →

QIH 2026-05-21

MSK Go

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

K-Number K260234

View Details →

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

View Details →

FTL 2026-05-21

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

Applicant Sofradim Production

K-Number K253956

View Details →

BSZ 2026-05-21

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

Applicant Drägerwerk AG Co. Kgaa

K-Number K252746

View Details →

IYN 2026-05-21

uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite

Applicant Wuhan United Imaging Healthcare Co.,Ltd

K-Number K253720

View Details →

OLR 2026-05-21

MuCover (proposed name) Oral Wound Dressing

Applicant MoleculeX Co., Ltd.

K-Number K253816

View Details →

OMP 2026-05-21

Nisus NPWT Canister 500-mL (CPC-500)

Applicant Cork Medical

K-Number K261291

View Details →

HGX 2026-05-21

Wearable Breast Pump (Model S39)

Applicant Shenzhen TPH Technology Co., Ltd.

K-Number K254244

View Details →

Page 122 of 14156

↑