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

MXD 2021-06-11

LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System

Applicant Medtronic, Inc.

K-Number K210484

View Details →

IYE 2021-06-10

Fiducial Marker

Applicant Carbon Medical Technologies, Inc.

K-Number K211590

View Details →

HEB 2021-06-10

Callaly Tampliner

Applicant Calla Lily Personal Care, Ltd.

K-Number K211469

View Details →

IYN 2021-06-10

Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K210699

View Details →

LYZ 2021-06-10

Disposable Vinyl Examination Gloves

Applicant Shandong Shengshixincheng Medical Science & Technology Co.,

K-Number K210522

View Details →

QIH 2021-06-10

syngo.via MI WorkFlows, Scenium, syngo MBF

Applicant Siemens Medical Solutions USA, Inc.

K-Number K211459

View Details →

BZG 2021-06-10

Spirometer

Applicant Mehow Innovative, Ltd.

K-Number K201493

View Details →

NUC 2021-06-10

H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for Two

Applicant CC Wellness, LLC

K-Number K210972

View Details →

MBH 2021-06-10

Symmetric Total Knee System

Applicant Signal Medical Corporation

K-Number K203779

View Details →

IYN 2021-06-10

M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K210416

View Details →

NUC 2021-06-10

H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit

Applicant CC Wellness, LLC

K-Number K210986

View Details →

FXX 2021-06-10

Disposable Surgical Mask

Applicant Lucky Textile Industrial(Wuxi) Co., Ltd.

K-Number K203756

View Details →

Page 1327 of 2685

↑