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

OLO 2019-10-10

Spine Wave Navigated Instruments

Applicant Spine Wave, Inc.

K-Number K192526

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BTT 2019-10-10

Palladium High Flow Therapy System

Applicant Vapotherm, Inc.

K-Number K191010

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MBF 2019-10-10

SMR Finned Short Stems

Applicant Lima Corporate S.P.A.

K-Number K191963

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FRG 2019-10-10

Halyard ONE-STEP* Sterilization Wrap

Applicant Owens & Minor (O&M) Halyard, Inc.

K-Number K192147

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FMF 2019-10-10

Instylla Delivery Kit

Applicant Instylla, Inc.

K-Number K191659

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FRG 2019-10-10

Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)

Applicant Mdk (Shanghai) Medical Packing Co., Ltd.

K-Number K182184

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ODP 2019-10-09

CORNICE Cervical Spacer System

Applicant Legend Spine Technologies

K-Number K192208

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HSB 2019-10-09

Pediatric Nailing PlatformFemur

Applicant OrthoPediatrics Corp.

K-Number K190321

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FMF 2019-10-09

Nipro Syringe

Applicant Nipro Medical Corporation

K-Number K191359

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LLZ 2019-10-09

DynaCAD

Applicant Invivo Corporation

K-Number K192200

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OUP 2019-10-09

The Cellfina System

Applicant Ulthera, Inc.

K-Number K192185

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DQX 2019-10-09

pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire

Applicant Phenox Limited

K-Number K191687

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