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

DQK 2021-03-11

WorkMate Claris System

Applicant Abbott

K-Number K210392

View Details →

KFM 2021-03-10

FloPump 57mL Centrifugal Pump

Applicant International Biophysics Corporation

K-Number K193663

View Details →

KWQ 2021-03-10

Lumbar Spine Truss System Plating Solution (LSTS-PS)

Applicant 4Web, Inc.

K-Number K203065

View Details →

FJK 2021-03-10

NovaLine Tubing Sets for Hemodialysis

Applicant Bain Medical Equipment (Guangzhou) Co., Ltd.

K-Number K201866

View Details →

MAX 2021-03-10

Hexanium TLIF

Applicant Spinevision, S.A.S.

K-Number K210359

View Details →

LRK 2021-03-10

Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)

Applicant Meris Investment Group

K-Number K203606

View Details →

EIH 2021-03-10

Non-Sterile Zirconia Block

Applicant Bioden Co., Ltd.

K-Number K201492

View Details →

NUH 2021-03-10

HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2

Applicant Hivox Biotek, Inc.

K-Number K203574

View Details →

KDI 2021-03-10

AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory

Applicant Baxter Healthcare Corportation

K-Number K201809

View Details →

FXX 2021-03-10

Surgical Face Mask

Applicant Wanxinda (Guangzhou) Technology Product Co., Ltd.

K-Number K202548

View Details →

HSN 2021-03-10

PROPHECY Preoperative Navigation Alignment System

Applicant Wrightmedicaltechnologyinc

K-Number K202815

View Details →

FXX 2021-03-10

Surgical Mask

Applicant Allmed Medical Products Co., Ltd.

K-Number K202411

View Details →

Page 1385 of 2685

↑