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

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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QNR 2023-08-25

VitalFlow Console

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

K-Number K230364

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NRY 2023-08-25

072 Aspiration System

Applicant Q'Apel Medical, Inc.

K-Number K222786

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NHA 2023-08-24

ZENEX FreeMilling & CCM Cast Abutment

Applicant Izenimplant Co., Ltd.

K-Number K231557

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NKB 2023-08-24

Zenius Spinal System

Applicant Medyssey USA, Inc.

K-Number K232218

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PYT 2023-08-24

Natural Cycles

Applicant Natural Cycles Nordic AB

K-Number K231274

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OUR 2023-08-24

CATAMARAN SI Joint Fusion System

Applicant Tenon Medical, Inc.

K-Number K231944

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