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

DQY 2019-06-28

Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4

Applicant Centerpoint Systems

K-Number K190475

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HTN 2019-06-28

MicroLink All-Suture Button Fixation System (Radiolucent)

Applicant Conmed Corporation

K-Number K190516

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LZA 2019-06-27

Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)

Applicant Comfort Rubber Gloves Industries Sdn. Bhd.

K-Number K190080

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CFN 2019-06-27

Human IgM Kit for use on SPAPlus

Applicant The Binding Site Group , Ltd.

K-Number K191465

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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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