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

ODP 2019-10-17

Matrix HA PEEK Cervical Implant System

Applicant Sapphire Medical Group

K-Number K192316

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PQK 2019-10-17

WavelinQ Plus EndoAVF System

Applicant C.R. Bard, Inc.

K-Number K192239

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GWM 2019-10-17

BcSs-PICNI-2000 Sensor

Applicant Braincare Desenvolvimento E Inovacao Tecnologica S.A.

K-Number K182073

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HWC 2019-10-16

SECURE Screw

Applicant A.M. Surgical, Inc.

K-Number K191771

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KTT 2019-10-16

Pitkar External Fixation System

Applicant S.H.Pitkar Orthotools Pvt. , Ltd.

K-Number K190486

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KPR 2019-10-16

DigiX FDX

Applicant Allengers Medical Systems Limited

K-Number K192541

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MQB 2019-10-16

Focus 35C Detector, Trimax 35C Detector

Applicant Iray Technology Taicang , Ltd.

K-Number K192512

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HRS 2019-10-16

Arthrex Minimally Invasive Ankle Fusion Plate

Applicant Arthrex, Inc.

K-Number K190953

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JWY 2019-10-16

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL

Applicant Thermo Fisher Scientific

K-Number K192250

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LLZ 2019-10-16

Ventripoint Medical System Plus (VMS+) 3.0

Applicant Ventripoint Diagnostics , Ltd.

K-Number K191493

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LHI 2019-10-15

Vial Adapter Ø20 mm

Applicant Avenir Performance Europeenne Medical (Apem)

K-Number K190149

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HRS 2019-10-15

Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module

Applicant Arthrex, Inc.

K-Number K191326

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