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

IZL 2024-09-20

ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)

Applicant Energy Resources International Co., Ltd.

K-Number K234108

View Details →

NRY 2024-09-20

Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

Applicant Perfuze, Ltd.

K-Number K242504

View Details →

MAX 2024-09-20

Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System

Applicant Alphatec Spine, Inc.

K-Number K242147

View Details →

FPA 2024-09-20

Ecomed Disposable Administration Sets

Applicant Ecomed Solutions, LLC

K-Number K234129

View Details →

GEX 2024-09-20

MTONE EVO (MTONE EVO)

Applicant M&T S.R.L.

K-Number K240604

View Details →

JDS 2024-09-20

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System

Applicant Smith & Nephew, Inc.

K-Number K240061

View Details →

MAX 2024-09-20

aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device

Applicant Carlsmed, Inc.

K-Number K241332

View Details →

IYN 2024-09-20

SuperSonic HepaVu

Applicant Supersonic Imagine

K-Number K242223

View Details →

FRO 2024-09-20

Derma-R Cream (Derma-R Cream)

Applicant Raya Pharmaceuticals, LLC

K-Number K240722

View Details →

FMF 2024-09-20

Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle

Applicant Sol-Millennium Medical, Inc.

K-Number K241821

View Details →

OLU 2024-09-20

NeuroField Analysis Suite

Applicant Neurofield, Inc.

K-Number K240420

View Details →

MRW 2024-09-20

zLOCK Lumbar Facet Fixation System

Applicant Zygofix , Ltd.

K-Number K242650

View Details →

Page 525 of 2738

↑