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

PJN 2019-10-10

Cranial PSI Accessory Anatomical Model Original, Cranial PSI Accessory Anatomical Model Modified, Cranial PSI Accessory Plastic Drawing Guide, Cranial PSI Accessory Cranial Implant Trial

Applicant Ossdsign AB

K-Number K190523

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DQA 2019-10-10

Belun Ring

Applicant Belun Technology Company Limited

K-Number K191417

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QID 2019-10-10

OraQuick Ebola Rapid Antigen Test

Applicant OraSure Technologies, Inc.

K-Number DEN190025

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FLL 2019-10-10

ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System

Applicant Fiab Spa

K-Number K192210

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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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