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

GIM 2023-08-25

BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes

Applicant Becton, Dickinson and Company

K-Number K213670

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MRH 2023-08-25

OMNI Surgical System

Applicant Sight Sciences, Inc.

K-Number K232214

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LLZ 2023-08-25

AIRAscore

Applicant Airamed GmbH

K-Number K223180

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QNR 2023-08-25

VitalFlowTM Centrifugal Pump

Applicant Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)

K-Number K223898

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GAT 2023-08-25

Non absorbable Surgical Polyester Suture

Applicant Shandong Haidike Medical Products Co., Ltd.

K-Number K231183

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FMI 2023-08-25

NovoFine® Plus

Applicant Novo Nordisk, Inc.

K-Number K231255

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OVB 2023-08-25

BioProtect Balloon Implant™ System

Applicant Bioprotect, Ltd.

K-Number K222972

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MQV 2023-08-25

Montage-QS Settable, Resorbable Bone Putty

Applicant Orthocon, Inc.

K-Number K231903

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FLL 2023-08-25

Reusable Temperature Probe, Disposable Temperature Probe

Applicant Shenzhen Sino-K Medical Technology Co.,Ltd

K-Number K223807

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JWY 2023-08-25

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL

Applicant Thermo Fisher Scientific

K-Number K231994

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GEI 2023-08-25

Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)

Applicant Kirwan Surgical Products, LLC

K-Number K231872

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FRG 2023-08-25

Sterilization Wrap

Applicant Wuhan Zonsen Medical Products Co., Ltd.

K-Number K223600

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