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

MQP 2017-08-31

CAPRI Corpectomy Cage System

Applicant K2m

K-Number K171704

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FRN 2017-08-31

Integrated Catch-up Freedom Syringe Driver Infusion System

Applicant Repro-Med Systems, Inc. Dba Rms Medical Products

K-Number K162613

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IYN 2017-08-31

DUS-7000 Digital Color Doppler Ultrasound System

Applicant Advanced Instrumentations, Inc.

K-Number K172055

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GZI 2017-08-30

MyndMove System, MyndMove Functional Electrical Stimulator

Applicant Myndtec, Inc.

K-Number K170564

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DXN 2017-08-30

Microlife Upper Arm Automatic Digital Blood Pressure Monitor

Applicant Microlife Intellectual Property GmbH

K-Number K170467

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OLO 2017-08-30

K2M Navigation Instruments

Applicant K2m

K-Number K171321

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OWI 2017-08-30

LigaPASS

Applicant Medicrea International SA

K-Number K172021

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LOD 2017-08-30

Refobacin Bone Cement R

Applicant Biomet, Inc.

K-Number K171540

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NUC 2017-08-30

Astroglide O Oil Personal Lubricant & Massage Oil

Applicant Biofilm, Inc.

K-Number K171985

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GEH 2017-08-30

truFreeze System

Applicant CSA Medical, Inc.

K-Number K171626

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GEH 2017-08-30

CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED

Applicant Cry IQ AB

K-Number K172049

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JWY 2017-08-30

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mL

Applicant Thermo Fisher Scientific

K-Number K172274

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