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

BTT 2026-01-16

FL-10000U Respiratory Humidifier

Applicant Flexicare Medical Limited.

K-Number K251448

View Details →

OWB 2026-01-16

Azurion R3.1

Applicant Philips Medical Systems B.V.

K-Number K254186

View Details →

ODP 2026-01-16

Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System

Applicant Curiteva, Inc.

K-Number K252205

View Details →

PCH 2026-01-16

Xpert GI Panel

Applicant Cepheid

K-Number K251721

View Details →

DHB 2026-01-16

NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg

Applicant Hycor Biomedical

K-Number K252775

View Details →

NHB 2026-01-16

SeptAlign

Applicant Spirair, Inc.

K-Number K251790

View Details →

QJP 2026-01-16

Toro 88 Superbore Catheter

Applicant Toro Neurovascular, Inc.

K-Number K252297

View Details →

NAY 2026-01-16

da Vinci Surgical System (IS5000)

Applicant Intuitive Surgical, Inc.

K-Number K251739

View Details →

GZJ 2026-01-16

actiTENS mini

Applicant Sublimed

K-Number K252767

View Details →

FJK 2026-01-16

VITAL Tubing Sets for Hemodialysis

Applicant Vital Healthcare Sdn. Bhd.

K-Number K251341

View Details →

QYN 2026-01-16

Sana Device

Applicant Sana Health

K-Number DEN250005

View Details →

SGY 2026-01-15

VitaSmart Hypothermic Oxygenated Perfusion System

Applicant Bridge TO Life, Ltd.

K-Number DEN250009

View Details →

Page 92 of 2685

↑