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

HBL 2024-07-26

DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)

Applicant Pro Med Instruments GmbH

K-Number K241883

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CGA 2024-07-26

EasyStat 300

Applicant Medica Corporation

K-Number K220328

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MRR 2024-07-26

Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K241800

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LHI 2024-07-26

Vent Vial Adapter

Applicant Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

K-Number K233287

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NKB 2024-07-26

Pantheon Pedicle Screw and Iliac Bolt Fixation System

Applicant Pantheon Spinal

K-Number K241494

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DRC 2024-07-26

Accusafe Transseptal Guidewire (GTR31180, GTR31230)

Applicant Synaptic Medical Corporation

K-Number K240246

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HQC 2024-07-26

Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)

Applicant Bausch and Lomb, Incorporated

K-Number K240169

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QAU 2024-07-26

Resolv Endoscopic Hemostat System

Applicant Hemostasis, LLC

K-Number K234131

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KPS 2024-07-26

Symbia SPECT and SPECT/CT Systems

Applicant Siemens Healthineers

K-Number K241898

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HIH 2024-07-26

ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)

Applicant Origyn Medical Technology (Hangzhou) Co., Ltd.

K-Number K240401

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OLO 2024-07-26

Spine Navigation System

Applicant Medivis, Inc.

K-Number K233725

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EZD 2024-07-26

Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)

Applicant Coloplast

K-Number K241028

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