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

OMP 2023-06-12

Genadyne Hybrid Foam Dressings

Applicant Genadyne Biotechnologies, Inc.

K-Number K221888

View Details →

DTN 2023-06-10

BMR 1900 PHISIO

Applicant Sorin Group Italia S.R.L.

K-Number K223361

View Details →

HSB 2023-06-09

Gamma4 System

Applicant Stryker GmbH

K-Number K230512

View Details →

EIH 2023-06-09

BruxZir TintEFX Coloring Liquid

Applicant Prismatik Dentalcraft, Inc.

K-Number K231347

View Details →

MAI 2023-06-09

Fixone Biocomposite Anchor

Applicant Aju Pharm Co., Ltd.

K-Number K230892

View Details →

JWH 2023-06-09

MyKnee UNI-ST

Applicant Medacta International S.A.

K-Number K231037

View Details →

NGX 2023-06-09

Bemer Therapy System Evo

Applicant Bemer Int AG

K-Number K231368

View Details →

IYN 2023-06-09

M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K230768

View Details →

MAX 2023-06-09

RODIN Expandable Lumbar Cage System

Applicant Ctl Medical Corporation

K-Number K231359

View Details →

GEI 2023-06-09

Renuvion® Micro Handpiece

Applicant Apyx Medical Corporation

K-Number K230586

View Details →

PLH 2023-06-09

OrthoPulse 2.0E (OPi2E-100)

Applicant Biolux Technology GmbH

K-Number K230905

View Details →

HGX 2023-06-09

Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)

Applicant Shenzhen Lutejiacheng Technology Co., Ltd.

K-Number K230776

View Details →

Page 795 of 2685

↑