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

NKB 2018-09-18

Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System

Applicant OrthoPediatrics Corp.

K-Number K181390

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GDW 2018-09-18

Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed

Applicant Ethicon Endo-Surgery, LLC

K-Number K181653

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DPS 2018-09-18

MAC VU360 Resting ECG Analysis System

Applicant Ge Medical Systems Information Technologies, Inc.

K-Number K173830

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GDW 2018-09-18

Endoscopic Linear Cutting Staplers and Loading Units for Single Use

Applicant Ezisurg (Suzhou) Medical Co., Ltd.

K-Number K181620

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MAX 2018-09-18

Sypher Spacer System

Applicant Biogennix, LLC

K-Number K181337

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MQV 2018-09-17

Ceracell Ortho Foam

Applicant Curasan AG

K-Number K181721

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GEX 2018-09-17

Venacure 1470 Pro

Applicant Quanta System Spa

K-Number K181632

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NAJ 2018-09-17

CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres

Applicant Suzhou Hengrui Callisyn Biomedical Co., Ltd.

K-Number K173871

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LOD 2018-09-17

PALACOS MV

Applicant Heraeus Medical GmbH

K-Number K182260

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OBR 2018-09-17

DenTek Ultimate Dental Guard

Applicant Medtech Products, Inc.

K-Number K180933

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NUH 2018-09-15

ThermaCare Quick Therapy TENS

Applicant Pfizer, Inc.

K-Number K181102

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CAF 2018-09-14

Portable Nebulizer

Applicant Microbase Technology Corporation

K-Number K180871

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