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

IRP 2021-06-17

Fist Assist Devices Model FA-1

Applicant Fist Assist Devices, LLC

K-Number K210281

View Details →

JAK 2021-06-17

Precise Position

Applicant Philips Healthcare (Suzhou) Co., Ltd.

K-Number K203514

View Details →

LRK 2021-06-16

Silent Nite Sleep Appliance with the Glidewell Hinge

Applicant Prismatik Dentalcraft, Inc.

K-Number K210694

View Details →

LZA 2021-06-16

AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)

Applicant Megine Industries Sdn Bhd

K-Number K211310

View Details →

LYZ 2021-06-16

Disposable Vinyl Examination Glove

Applicant Inner Mongolia Cureguard Medical Materials Co., Ltd.

K-Number K211336

View Details →

IMK 2021-06-16

iBOT Personal Mobility Device (iBOT PMD)

Applicant Mobius Mobility

K-Number K210920

View Details →

LIT 2021-06-16

Sublime Radial Access 018 RX Dilatation Catheter

Applicant Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,

K-Number K211044

View Details →

FXX 2021-06-16

Disposable Medical Surgical Face Mask

Applicant Guangdong Haiou Medical Apparatus Co., Ltd.

K-Number K203200

View Details →

LLZ 2021-06-16

Qmenta Care Platform Family

Applicant Mint Labs, Inc., D/B/A. Qmenta

K-Number K202718

View Details →

OLZ 2021-06-16

EnsoSleep

Applicant Ensodata, Inc.

K-Number K210034

View Details →

MVM 2021-06-16

Aptiva Celiac Disease IgA Reagent

Applicant Inova Diagnostics, Inc.

K-Number K193604

View Details →

MAX 2021-06-15

SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers

Applicant Camber Spine Technologies, LLC

K-Number K210595

View Details →

Page 1324 of 2685

↑