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

SCV 2025-12-16

Versius Surgical System (Versius Plus)

Applicant Cmr Surgical Limited

K-Number K252111

View Details →

DXQ 2025-12-16

Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)

Applicant Baxter Healthcare Corporation

K-Number K251745

View Details →

HSX 2025-12-16

Cambridge Partial Knee

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K251771

View Details →

GAM 2025-12-16

TroClose 1200

Applicant Gordian Surgical, Ltd.

K-Number K253620

View Details →

LJS 2025-12-16

BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology

Applicant Spectrum Vascular

K-Number K252373

View Details →

PPW 2025-12-16

prolaio eVO2peak Module (Version 1.0)

Applicant Prolaio, Inc.

K-Number K252204

View Details →

QPC 2025-12-16

VR® Personal Protective Level 3 Gown (VR Gowns)

Applicant PolyConversions, Inc.

K-Number K252940

View Details →

CAW 2025-12-16

V series portable oxygen concentrator (V5, V5C, V6, V6C)

Applicant Shenzhen Harveymed Technology Co., Ltd.

K-Number K252268

View Details →

FGB 2025-12-16

Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F)

Applicant Guangzhou Red Pine Medical Instrument Co., Ltd.

K-Number K251951

View Details →

FGB 2025-12-16

Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)

Applicant Zhejiang Geyi Medical Instrument Co., Ltd.

K-Number K252468

View Details →

QIH 2025-12-16

IRISeg

Applicant Intuitive Surgical, Inc.

K-Number K251763

View Details →

OWB 2025-12-16

SKAN C PULSAR

Applicant Skanray Technologies Limited

K-Number K251893

View Details →

Page 186 of 2728

↑