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

BSP 2018-02-02

IMD's Lumbar Puncture Needle

Applicant International Medical Development, Inc.(Imd)

K-Number K170112

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NDC 2018-02-02

Glooko Mobile Insulin Dosing System

Applicant Glooko, Inc.

K-Number K171450

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MQP 2018-02-02

Camber Spine Technologies SPIRA - V Open Matrix Corpectomy Cage

Applicant Camber Spine Technologies

K-Number K173800

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ONG 2018-02-02

SMAXEL CO2 Surgical Laser System

Applicant Ids, Ltd.

K-Number K180036

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MQV 2018-02-02

Bicera Resorbable Bone Substitute

Applicant Wiltrom Corporation Limited

K-Number K172237

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LCX 2018-02-02

ACRO HCG Pregnancy Rapid Test

Applicant Acro Biotech, Inc.

K-Number K172512

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OQO 2018-02-01

Sentosa SA201 HSV 1/2 Qualitative PCR Test

Applicant Vela Diagnostics USA, Inc.

K-Number K172509

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KOD 2018-02-01

Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter

Applicant Cook Incorporated

K-Number K171662

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IYN 2018-02-01

ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K173957

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NKG 2018-02-01

The Solstice OCT System

Applicant Life Spine, Inc.

K-Number K173047

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NHA 2018-02-01

PREMIUM Implant Systems SHELTA Implant Systems

Applicant Sweden & Martina S.P.A.

K-Number K161989

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FRC 2018-02-01

Sporview VH202 BI

Applicant Spsmedical Supply Corp. A Division of Cantel Medical

K-Number K171287

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