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

LZA 2021-12-16

Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs

Applicant Rimba Glove Snd Bhd

K-Number K212898

View Details →

OHT 2021-12-16

IPL hair removal machine

Applicant Shenzhen Borria Technology Co., Ltd.

K-Number K213020

View Details →

GEI 2021-12-16

Voyant Fine Fusion Device (EB230)

Applicant Applied Medical

K-Number K202818

View Details →

FXX 2021-12-16

LM Surgical Mask Level 3, LM Surgical Mask Level 2,

Applicant Liberty Mask, LLC

K-Number K211378

View Details →

FYA 2021-12-16

Surgical Gown, Model: surgical gown-hp-3

Applicant Weihai Dishang Medical Technology Co., Ltd.

K-Number K210355

View Details →

LXB 2021-12-16

Ponto 5 SuperPower

Applicant Oticon Medical AB

K-Number K213733

View Details →

FMI 2021-12-16

UltiCare Disposable Pen Needles

Applicant Ultimed Incorporated

K-Number K213407

View Details →

GCJ 2021-12-16

Connected OR Hub with Device and Voice Control

Applicant Stryker Corporation

K-Number K212055

View Details →

LLZ 2021-12-16

Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio

Applicant Brainlab AG

K-Number K212420

View Details →

HQF 2021-12-16

Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo

Applicant Ellex Medical Pty, Ltd.

K-Number K212630

View Details →

QKB 2021-12-16

VBrain

Applicant Vysioneer, Inc.

K-Number K213628

View Details →

OHS 2021-12-15

reVive Light Therapy Essentials

Applicant Led Technologies, Inc.

K-Number K210965

View Details →

Page 1264 of 2744

↑