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

PYT 2021-02-18

Clue Birth Control

Applicant Biowink GmbH

K-Number K193330

View Details →

LLZ 2021-02-18

PhantomMSK Hip

Applicant OrthoGrid Systems, Inc.

K-Number K210136

View Details →

FXX 2021-02-18

Surgical Face Mask (non-sterile)

Applicant Nantong Taiweishi Medical Technology Co., Ltd.

K-Number K203426

View Details →

FLL 2021-02-18

Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60

Applicant Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.

K-Number K202687

View Details →

EOX 2021-02-18

EsoCheck Cell Collection Device

Applicant Lucid Diagnostics, Inc.

K-Number K210137

View Details →

DZE 2021-02-17

s-Clean SQ-SL Implant System Regular

Applicant Dentis Co., Ltd.

K-Number K210132

View Details →

HSB 2021-02-17

FITBONE(R) TAA

Applicant Wittenstein Intens GmbH

K-Number K203399

View Details →

KGO 2021-02-17

Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein

Applicant Eco Medi Glove Sdn. Bhd.

K-Number K202401

View Details →

DXC 2021-02-17

VIOLA

Applicant Vascular Graft Solutions, Ltd.

K-Number K203307

View Details →

JWH 2021-02-17

iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System

Applicant Conformis, Inc.

K-Number K210252

View Details →

MBB 2021-02-17

SpaceFlex Shoulder

Applicant G21, S.R.L.

K-Number K202338

View Details →

JAK 2021-02-16

VesselIQ Xpress

Applicant GE Medical Systems SCS

K-Number K200626

View Details →

Page 1403 of 2685

↑