Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

OBJ 2019-06-27

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System

Applicant Acist Medical Systems, Inc.

K-Number K191175

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JAK 2019-06-27

SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence

Applicant Siemens Medical Solutions USA, Inc.

K-Number K190578

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GAM 2019-06-27

VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture

Applicant ETHICON, Inc.

K-Number K183183

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POV 2019-06-27

SwimCount Sperm Quality Test

Applicant Motilitycount Aps

K-Number K183602

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KGO 2019-06-27

FlexGard Cut-Resistant Glove Liners

Applicant Ldi Corporation

K-Number K190782

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KMF 2019-06-27

Rochal Bioshield Silicone Film

Applicant Rochal Industries, LLC

K-Number K182733

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JAI 2019-06-27

Z-Robot Patient Positioning System

Applicant Chinan Biomedical Technology, Inc.

K-Number K182683

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NXC 2019-06-27

DynaFlex

Applicant Dyna Flex

K-Number K190583

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LNH 2019-06-27

LiverMultiScan (LMSv3)

Applicant Perspectum Diagnostics, Ltd.

K-Number K190017

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OCX 2019-06-27

ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector

Applicant Erbe USA, Inc.

K-Number K191438

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NHA 2019-06-26

Straumann CARES Screw-Retained Bridges and Bars

Applicant Institut Straumann AG

K-Number K190097

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PMC 2019-06-26

DigniCap Delta

Applicant Dignitana, Inc.

K-Number K191166

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