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 2017-08-11

Paonan Armstrong Posterior Spinal Fixation System

Applicant Paonan Biotech Co., Ltd.

K-Number K161225

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BSR 2017-08-11

Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip

Applicant Cook Incorporated

K-Number K162729

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PFX 2017-08-11

GenetiSure Dx Postnatal Assay

Applicant Agilent Technologies, Inc.

K-Number K163367

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MAX 2017-08-11

ShurFit 2C Lumbar Interbody Fusion System

Applicant Precision Spine, Inc.

K-Number K171657

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OBH 2017-08-11

SOZO

Applicant ImpediMed Limited

K-Number K172122

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KDI 2017-08-11

Diacap Pro Dialyzer

Applicant B. Braun Avitum AG

K-Number K170574

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QEX 2017-08-10

MegaVac Mechanical Thrombectomy System

Applicant Capture Vascular, Inc.

K-Number K171493

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MSH 2017-08-10

3M VFlex Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S

Applicant 3M Healthcare

K-Number K171116

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OWB 2017-08-10

OEC Elite

Applicant Ge Oec Medical Systems, Inc.

K-Number K171565

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PST 2017-08-10

HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm

Applicant Biostable Science & Engineering, Inc.

K-Number K171431

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HSB 2017-08-10

Zimmer Natural Nail System

Applicant Zimmer, Inc.

K-Number K172114

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OOE 2017-08-10

LENSAR Laser System fs 3D (LLS-fs 3D)

Applicant Lensar, Inc.

K-Number K171337

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