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

OVD 2018-09-13

DYNA-LINK ELITE Stand-Alone Anterior Lumbar System

Applicant Life Spine, Inc.

K-Number K180215

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DQY 2018-09-13

SelectFlex 072 Neurovascular Access System

Applicant Q'Apel

K-Number K181000

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NKB 2018-09-13

MOSS VRS Spinal System

Applicant Biedermann Motech GmbH & Co. KG

K-Number K181821

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JWY 2018-09-13

MTS Penicillin 0.002- 32 µg/mL

Applicant Liofilchem s.r.l.

K-Number K181889

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MQV 2018-09-13

Sorrento Bioglass Bone Graft Substitute

Applicant Xenco Medical, LLC

K-Number K173933

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OCX 2018-09-13

Seal Single Use Biopsy Valve

Applicant Boston Scientific Corporation

K-Number K182275

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OBO 2018-09-13

Spectralis HRA+OCT and variants with OCT Angiography Module

Applicant Heidelberg Engineering GmbH

K-Number K181594

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DZJ 2018-09-13

KLS Martin Individual Patient Solutions (IPS) Planning System

Applicant KLS-Martin L.P.

K-Number K181241

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PCC 2018-09-13

TENS device-HeadaTerm, eEspress

Applicant Wat Medical Technology (Ningbo) Co., Ltd.

K-Number K172450

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OAS 2018-09-13

Planmeca Viso

Applicant Planmeca Oy

K-Number K181576

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FAD 2018-09-13

Sof-Flex Ureteral Stent Set

Applicant Cook Incorporated

K-Number K180053

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EHD 2018-09-13

RiX70 DC

Applicant Trident S.R.L

K-Number K182206

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