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

DYB 2024-08-14

Catapult Guide Sheath

Applicant Contract Medical International, GmbH

K-Number K240957

View Details →

QSY 2024-08-14

TRAUMAGEL®

Applicant Cresilon, Inc.

K-Number K240713

View Details →

LPL 2024-08-14

Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)

Applicant X-Cel Specialty Contacts, A Walman Optical Company

K-Number K242059

View Details →

CBK 2024-08-14

Family of DIMAR DMAX NIV masks

Applicant Dimar S.P.A.

K-Number K232836

View Details →

HFE 2024-08-14

Utepreva Endometrial Sampler (UP01)

Applicant Utepreva, LLC

K-Number K240595

View Details →

DQX 2024-08-14

CROSSLEAD Tracker

Applicant Asahi Intecc Co., Ltd.

K-Number K241510

View Details →

HDX 2024-08-14

Intimate Rose Vaginal Dilators

Applicant Plus EV Holdings Dba Intimate Rose

K-Number K241748

View Details →

NGL 2024-08-14

Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel

Applicant Qingdao Hightop Biotech Co., Ltd.

K-Number K241969

View Details →

GXD 2024-08-14

COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)

Applicant Avanos Medical, Inc.

K-Number K242057

View Details →

LLZ 2024-08-13

Bullsai

Applicant Turing Medical Technologies, Inc.

K-Number K241094

View Details →

ITI 2024-08-13

Power wheelchair (N6101)

Applicant Zhejiang Zhonglei Medical Technology Co. , Ltd.

K-Number K241686

View Details →

LCX 2024-08-13

Shinetell Digital Pregnancy Test

Applicant Hangzhou AllTest Biotech Co., Ltd.

K-Number K241978

View Details →

Page 552 of 2738

↑