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FDA 510(k) 许可

由 MedTracker 跟踪的 510(k) 许可设备

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

申请人 Spectrum Vascular

K 编号 K252373

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PPW 2025-12-16

prolaio eVO2peak Module (Version 1.0)

申请人 Prolaio, Inc.

K 编号 K252204

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QPC 2025-12-16

VR® Personal Protective Level 3 Gown (VR Gowns)

申请人 PolyConversions, Inc.

K 编号 K252940

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CAW 2025-12-16

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

申请人 Shenzhen Harveymed Technology Co., Ltd.

K 编号 K252268

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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)

申请人 Guangzhou Red Pine Medical Instrument Co., Ltd.

K 编号 K251951

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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)

申请人 Zhejiang Geyi Medical Instrument Co., Ltd.

K 编号 K252468

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QIH 2025-12-16

IRISeg

申请人 Intuitive Surgical, Inc.

K 编号 K251763

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OWB 2025-12-16

SKAN C PULSAR

申请人 Skanray Technologies Limited

K 编号 K251893

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OVK 2025-12-16

ADVIA Centaur Cytokeratin Fragment 21-1

申请人 Fujirebio Diagnostics,Inc.

K 编号 K250925

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BZD 2025-12-15

SleepRes PAP System

申请人 Sleepres, Inc.

K 编号 K251770

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LKF 2025-12-15

FemVue® Controlled Saline-Air Device (FSA-300)

申请人 Femasys, Inc.

K 编号 K253403

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DYB 2025-12-15

V•Stick™ Vascular Access Set

申请人 Argon Medical Devices, Inc.

K 编号 K253741

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