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

OCX 2023-08-14

ENDOGATOR Hybrid Irrigation Tubing

Applicant Medivators

K-Number K231418

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HBW 2023-08-14

Stryker Resorbable Fixation System

Applicant Stryker Leibinger GmbH & Co KG

K-Number K231208

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GEX 2023-08-14

V-Laser

Applicant Wontech Co., Ltd.

K-Number K231054

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GEI 2023-08-14

Density

Applicant Jeisys Medical, Inc.

K-Number K230663

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NKB 2023-08-14

LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System

Applicant L&K BIOMED Co., Ltd.

K-Number K232311

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OVE 2023-08-14

SPICCA Stand-Alone Cervical Fusion Cages

Applicant Southern Medical (Pty) , Ltd.

K-Number K230608

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NHA 2023-08-14

DESS Dental Smart Solutions

Applicant Terrats Medical SL

K-Number K231434

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LLZ 2023-08-14

SaintView

Applicant Inviz Corporation

K-Number K223660

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KNS 2023-08-14

Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome

Applicant Boston Scientific Corporation

K-Number K232162

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NGT 2023-08-12

Pre-Filled Normal Saline Flush Syringe

Applicant Anhui Tianyang Pharmaceutical Co., Ltd.

K-Number K223584

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NGT 2023-08-12

TK Pre-Filled Normal Saline Flush Syringe

Applicant Anhui Tiankang Medical Technology Co., Ltd.

K-Number K230756

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DQA 2023-08-12

Pulse Oximeter

Applicant Beijing Choice Electronic Technology Co., Ltd.

K-Number K230172

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