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

HSX 2026-04-02

Tahoe Unicondylar Knee System with TiNbN Overcoat

Applicant Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics

K-Number K260796

View Details →

SEP 2026-04-02

Onclarity™ Self-Collection Kit

Applicant Becton, Dickinson and Company

K-Number K260184

View Details →

KPE 2026-04-02

Disposable Infusion Bag for Parenteral Nutrition

Applicant Beijing L&Z Medical Technology Development Co., Ltd.

K-Number K252079

View Details →

JEY 2026-04-02

Leforte MMF System

Applicant Jeil Medical Corporation

K-Number K252246

View Details →

HLZ 2026-04-01

RM Electrode (RMH 25-01)

Applicant Retmap, Inc.

K-Number K253586

View Details →

ODP 2026-04-01

MOD-C

Applicant Orthomod, LLC

K-Number K242303

View Details →

MOS 2026-04-01

GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only

Applicant Shenzhen RF Tech Co., Ltd.

K-Number K252876

View Details →

FOZ 2026-04-01

Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)

Applicant Poly Medicure Limited

K-Number K252513

View Details →

QIH 2026-04-01

CoLumbo C-Spine

Applicant Smart Soft Healthcare AD

K-Number K254015

View Details →

GEI 2026-04-01

Prana System

Applicant Prana Surgical

K-Number K253405

View Details →

HRS 2026-04-01

enHAnce PEEK Bunion System

Applicant Nvision Biomedical Technologies, Inc.

K-Number K253718

View Details →

DXN 2026-04-01

Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro

Applicant Shenzhen AOJ Medical Technology Co., Ltd.

K-Number K260276

View Details →

Page 109 of 2728

↑