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 2017-04-14

Threshold V2 Pedicular Fixation System

Applicant Spineology, Inc.

K-Number K170255

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NKB 2017-04-14

Threshold Pedicular Fixation System

Applicant Spineology, Inc.

K-Number K170251

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GXI 2017-04-13

Coolief* Cooled RF Probe

Applicant Halyard Health, Inc.

K-Number K163461

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ECX 2017-04-13

Intelli-Ox

Applicant Air Liquide Healthcare America Corporation

K-Number K161179

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JAI 2017-04-13

Patient Positioning System

Applicant Forte Automation Systems, Inc.

K-Number K170502

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IYN 2017-04-13

Interson USB Ultrasound System

Applicant Interson Corporation

K-Number K163443

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GEI 2017-04-13

PlasmaBlade T

Applicant Medtronic Advanced Energy

K-Number K170610

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HWC 2017-04-13

MICATM Screw System

Applicant Wrightmedicaltechnologyinc

K-Number K162353

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MQP 2017-04-13

CAPRI Corpectomy Cage System

Applicant K2m

K-Number K170055

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ODG 2017-04-13

PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner

Applicant Pentax of America, Inc.

K-Number K162447

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HRS 2017-04-13

Additive Orthopaedics Locking Lattice Plate

Applicant Additive Orthopaedics, LLC

K-Number K170214

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OVD 2017-04-13

Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device

Applicant Titan Spine, LLC

K-Number K163269

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