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

DQA 2026-05-29

Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)

Applicant Philips Medizin Systeme Böblingen GmbH

K-Number K252821

View Details →

CCJ 2026-05-29

CoSense ETCO Monitor

Applicant Capnia, Inc.

K-Number K253119

View Details →

GEI 2026-05-29

ENTire IRE System

Applicant Entire Medical , Ltd.

K-Number K261202

View Details →

OLO 2026-05-29

Navigated LLIF Impactable Tracker

Applicant Tyber Medical, LLC

K-Number K261060

View Details →

GEX 2026-05-29

LUNE PureHygiene

Applicant Enamel Pure

K-Number K260138

View Details →

DQK 2026-05-29

ZEUS Platform (FG0501US)

Applicant iRhythm Technologies, Inc.

K-Number K252859

View Details →

QIH 2026-05-29

OrthoGrid Hip AI® 4.0

Applicant OrthoGrid Systems, Inc.

K-Number K260077

View Details →

QTZ 2026-05-29

HistoSonics® Planning Tool

Applicant HistoSonics, Inc.

K-Number K252947

View Details →

LPL 2026-05-29

Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus

Applicant INTEROJO, Inc.

K-Number K260507

View Details →

QNP 2026-05-29

GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)

Applicant Cosmo Artificial Intelligence - Ai, Ltd.

K-Number K261369

View Details →

CAW 2026-05-29

Oxygen Concentrator (OX-5A, OX-5C)

Applicant Oxytek Medical Technology Co., Ltd.

K-Number K252965

View Details →

MAX 2026-05-29

Exceed® Biplanar Expandable Interbody System

Applicant Spine Wave, Inc.

K-Number K261159

View Details →

Page 115 of 14156

↑