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

OMP 2022-07-26

Invia Ease Negative Pressure Wound Therapy (NPWT) System

Applicant Medela AG

K-Number K214112

View Details →

PGY 2022-07-26

LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)

Applicant Qingdao Hisense Medical Equipment Co., Ltd.

K-Number K221567

View Details →

MBI 2022-07-26

Parcus Synd-EZ SS

Applicant Parcus Medical, LLC

K-Number K221502

View Details →

KWQ 2022-07-26

VyPlate Anterior Cervical Plate System

Applicant Vy Spine, LLC

K-Number K221572

View Details →

KNT 2022-07-26

Gastric Lightguide (GLG)

Applicant Naser Dib Gabinet Lekarksi Nasmed

K-Number K212407

View Details →

JWH 2022-07-26

Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)

Applicant Conformis, Inc.

K-Number K221404

View Details →

JWH 2022-07-26

Cemented Round Patella with JRNY Pegs

Applicant Smith & Nephew, Inc.

K-Number K221939

View Details →

QQX 2022-07-25

BioFire COVID-19 Test 2

Applicant Biofire Defense, LLC

K-Number K221460

View Details →

QAS 2022-07-25

Viz SDH

Applicant Viz. Ai, Inc.

K-Number K220439

View Details →

NRY 2022-07-25

Tigertriever 13 Revascularization Device

Applicant Rapid Medical , Ltd.

K-Number K220808

View Details →

EOQ 2022-07-25

Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2

Applicant Ambu A/S

K-Number K220606

View Details →

FXX 2022-07-25

Paneffort 3-ply Surgical and Procedural Masks

Applicant Paneffort, LLC

K-Number K221409

View Details →

Page 1101 of 2738

↑