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

FYA 2020-03-16

AERO CHROME* Breathable Performance Surgical Gowns

Applicant O&M Halyard, Inc.

K-Number K200522

View Details →

OWI 2020-03-16

Response BandLoc Spinal Fixation

Applicant OrthoPediatrics Corp.

K-Number K200097

View Details →

JAK 2020-03-16

Al-Rad Companion (Musculoskeletal)

Applicant Siemens Medical Solutions USA, Inc.

K-Number K193267

View Details →

CAH 2020-03-16

Altera Filter and HME/Filter

Applicant Meditera Tibbi Malzeme San VE Tic AS

K-Number K192713

View Details →

DDG 2020-03-16

Transferrin

Applicant Biosystems S.A.

K-Number K190495

View Details →

NUH 2020-03-14

Health Expert Electronic Stimulator (model: AST-300L)

Applicant Shenzhen Osto Technology Company Limited

K-Number K190783

View Details →

GXR 2020-03-13

NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate

Applicant Neurovention, LLC

K-Number K192162

View Details →

KDI 2020-03-13

PrisMax System Version 3

Applicant Baxter Healthcare Corporation

K-Number K193482

View Details →

JWH 2020-03-13

iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System

Applicant Conformis, Inc.

K-Number K193105

View Details →

QKM 2020-03-13

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

Applicant 3M Healthcare

K-Number K193110

View Details →

PGY 2020-03-13

32HL512D

Applicant Lg Electronics.Inc

K-Number K192925

View Details →

JWH 2020-03-13

LEGION Inserts with JRNY Lock

Applicant Smith & Nephew, Inc.

K-Number K200407

View Details →

Page 1695 of 2744

↑