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

FRO 2019-09-12

Saline Wound Wash, SteriCleanse(TM)

Applicant Ascent Consumer Products, Inc.

K-Number K183662

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PML 2019-09-12

Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K191148

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IPL 2019-09-12

UPnRIDE

Applicant Upnride Robotics , Ltd.

K-Number K182257

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OHS 2019-09-12

faceLITE

Applicant Ismart Marketing Svcs, Ltd.

K-Number K191629

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GZI 2019-09-12

L360 Thigh System

Applicant Bioness, Inc.

K-Number K191587

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MAX 2019-09-12

Republic Spine Restore Intervertebral Body Fusion System

Applicant Republic Spine, LLC

K-Number K190398

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MAX 2019-09-12

Ali Interbody Fusion System

Applicant Raed M. Ali, M.D., Inc.

K-Number K191516

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MCW 2019-09-12

Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire

Applicant Rex Medical, L.P.

K-Number K191419

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NKB 2019-09-12

mont blanc & mont blanc MIS Spinal Systems

Applicant Spineway SA

K-Number K191726

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OAP 2019-09-12

Capillus 112, Capillus 244

Applicant Capillus

K-Number K192012

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GEX 2019-09-12

CO2 Laser System

Applicant Shenzhen Gsd Tech Co., Ltd.

K-Number K191518

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LLZ 2019-09-12

syngo Application Software

Applicant Siemens Medical Solution USA, Inc.

K-Number K190780

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