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

MMI 2019-03-04

Dimension Vista High-Sensitivity Troponin I (TNIH) Assay

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K182225

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BSO 2019-03-04

Medline Reinforced Epidural Catheter

Applicant Medline Industries, Inc.

K-Number K181782

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NUC 2019-03-04

JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant

Applicant United Consortium

K-Number K183384

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DXN 2019-03-03

Electronic Blood Pressure Monitor

Applicant Shenzhen Jumper Medical Equipment Co., Ltd.

K-Number K182495

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FRG 2019-03-01

Vis-U-All Low Temperature Sterilization Pouch/Tubing

Applicant STERIS Corporation

K-Number K183401

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FMI 2019-03-01

BD Vacutainer Eclipse UltraFill Blood Collection Needle

Applicant Becton, Dickinson and Company

K-Number K181730

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DQA 2019-03-01

Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System

Applicant Taiwan Aulisa Medical Devices Technologies, Inc.

K-Number K182822

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LLZ 2019-03-01

ClearON Mobile

Applicant Rayence Co., Ltd.

K-Number K183478

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MUH 2019-03-01

ODI HD Dental Sensor

Applicant Cnd Global Technologies, Inc.

K-Number K190234

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MAX 2019-03-01

Idys TLIF TiVac

Applicant Clariance, Sas

K-Number K183259

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KNG 2019-03-01

Fetal Doppler, Model FD88

Applicant Shenzzhen Luckcome Technology Inc., Ltd.

K-Number K182710

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KCT 2019-03-01

PRO-LITE Sterilization Tray

Applicant STERIS Corporation

K-Number K183402

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