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

ODP 2026-04-13

HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES

Applicant HC Biologics, LLC

K-Number K260340

View Details →

MBF 2026-04-13

Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

Applicant Zimmer, Inc.

K-Number K253592

View Details →

DYB 2026-04-13

Aventus Introducer Sheath

Applicant Inquis Medical

K-Number K260091

View Details →

QVP 2026-04-13

Elecsys Anti-SARS-CoV-2 S

Applicant Roche Diagnostics

K-Number K252280

View Details →

BTT 2026-04-13

HVT 2.0

Applicant Vapotherm, Inc.

K-Number K254078

View Details →

MHX 2026-04-10

Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)

Applicant Shanghai Draeger Medical Instrument Co., Ltd.

K-Number K252250

View Details →

KPR 2026-04-10

AeroDR TX c02

Applicant Dk Medical Systems Co., Ltd.

K-Number K253446

View Details →

CHL 2026-04-10

ABL90 FLEX PLUS System, safeCLINITUBES

Applicant Radiometer Medicals Aps

K-Number K252207

View Details →

GEI 2026-04-10

Ascblue (8010)

Applicant Ascblue Corporation

K-Number K253777

View Details →

QKB 2026-04-10

DeepBT Detector-Plus

Applicant Aitewan Biomedical Technology, Inc.

K-Number K252190

View Details →

HRS 2026-04-10

SMART Osteotomy System

Applicant Actis Medical Pty., Ltd.

K-Number K260090

View Details →

GDW 2026-04-10

Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads

Applicant Covidien (Part of Medtronic)

K-Number K253657

View Details →

Page 153 of 14156

↑