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Recently FDA-cleared medical devices

Every device we hold with a US FDA 510(k) clearance decided in the last 12 months, newest first. Each one links through to its full regulatory record.

3,670 devices · when each source was last refreshed

Registers: US (FDA) · UK (MHRA) · CA (Health Canada) · AU (TGA) · EU (EUDAMED)

Device
Electric Wheelchair (CN501)

Zhejiang Shimo Technology Co., Ltd.

Cleared 2026-10-13

Registered with
  • US (FDA)
Helo™ Return

Endovascular Engineering

Cleared 2026-10-11

Registered with
  • US (FDA)
Fertilis microICSI Device

Fertilis Pty Ltd

Cleared 2026-10-09

Registered with
  • US (FDA)
  • AU (TGA)
Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500)

Shenzhen Jianchao Intelligent Technology Co., Ltd.

Cleared 2026-10-09

Registered with
  • US (FDA)
Wishbone HAE

Wishbone SA

Cleared 2026-10-09

Registered with
  • US (FDA)
IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202)

Shenzhen Jianchao Intelligent Technology Co., Ltd.

Cleared 2026-10-09

Registered with
  • US (FDA)
TruVision Single-Use 1.9mm Arthroscopy System

Nexus Cmf, LLC

Cleared 2026-10-09

Registered with
  • US (FDA)
CMF Titanium Splints

Materialise N.V

Cleared 2026-10-09

Registered with
  • US (FDA)
The D-Tip Denudation Pipette

Allwin Medical Devices Inc

Cleared 2026-10-09

Registered with
  • US (FDA)
VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System.

VivaChek Biotech (Hangzhou) Co, Ltd

Cleared 2026-10-09

Registered with
  • US (FDA)
CarboClear® Cervical Navigated Instruments

CarboFix Orhtopedics , Ltd.

Cleared 2026-10-09

Registered with
  • US (FDA)
Excelsior Reach Microcatheter

STRYKER NEUROVASCULAR

Cleared 2026-10-09

Registered with
  • US (FDA)
Rapid ICH (v4.0)

Ischemaview, Inc.

Cleared 2026-10-09

Registered with
  • US (FDA)
Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler

MEDICAL COMPONENTS, INC.

Cleared 2026-10-09

Registered with
  • US (FDA)
Sleep Analysis Module

Neurotronics, LLC

Cleared 2026-10-09

Registered with
  • US (FDA)
ECHELON Synergy

FUJIFILM Corporation

Cleared 2026-10-09

Registered with
  • US (FDA)
  • EU (EUDAMED)
Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG)

CathRx, Ltd.

Cleared 2026-10-09

Registered with
  • US (FDA)
Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic Ultrasound System (Resona I10);Diagnostic Ultrasound System (Resona I10S);Diagnostic Ultrasound System (Resona XI);Diagnostic Ultrasound System (Resona I10 CV);Diagnostic Ultrasound System (Nuewa I10W);Diagnostic Ultrasound System (Nuewa I10 Exp);Diagnostic Ultrasound System (Nuewa I10);Diagnostic Ultrasound System (Nuewa I10S);Diagnostic Ultrasound System (Nuewa XI);Diagnostic Ultrasoun

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Cleared 2026-10-08

Registered with
  • US (FDA)
MeCare Alpha (MCA2019)

Ivt Medical , Ltd.

Cleared 2026-10-08

Registered with
  • US (FDA)
Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+ 10mm iQ+ Blade (5500-26B-010); Sonopet iQ+ 20mm iQ+ Blade (5500-26B-020); Sonopet iQ+ 11cm iQ+ Apex Knife (5500-26B-114); Sonopet iQ+ 12cm iQ+ Apex 360 (5500-26B-312); Sonopet iQ+ 12cm iQ+ Claw (5500-26B-328)

Stryker Instruments

Cleared 2026-10-08

Registered with
  • US (FDA)
NEXT-Cue

Neuroxt, Inc.

Cleared 2026-10-08

Registered with
  • US (FDA)
CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight Medical Diode Laser Systems (S3-BF30);CureLight Medical Diode Laser Systems (S2-F15);CureLight Medical Diode Laser Systems (S2-H7.5)

Wuhan PHOMED Technology Company , Ltd.

Cleared 2026-10-08

Registered with
  • US (FDA)
V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10 Diagnostic Ultrasound System; XH10 Diagnostic Ultrasound System; V10 ONE Diagnostic Ultrasound System; cV10 ONE Diagnostic Ultrasound System; H10 ONE Diagnostic Ultrasound System; XV10 ONE Diagnostic Ultrasound System; XH10 ONE Diagnostic Ultrasound System; HERA Z10 Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

Cleared 2026-10-08

Registered with
  • US (FDA)
One Coat Bond; One Coat Bond SL

Dent4You AG

Cleared 2026-10-08

Registered with
  • US (FDA)
Vista AI Scan

Vista Ai, Inc.

Cleared 2026-10-07

Registered with
  • US (FDA)
Dr.AlignNavi

InnoDtech, Inc.

Cleared 2026-10-07

Registered with
  • US (FDA)
eClinics

Ceiba Healthcare US, Inc.

Cleared 2026-10-07

Registered with
  • US (FDA)
Diode Laser Hair Removal Machine (QDTM-03)

Beijing Nubway S&T Co., Ltd.

Cleared 2026-10-07

Registered with
  • US (FDA)
APEX 3D S Diamond Tibia

Paragon 28, Inc

Cleared 2026-10-07

Registered with
  • US (FDA)
prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments

Centinel Spine

Cleared 2026-10-07

Registered with
  • US (FDA)
B. anthracis Real-time PCR Assay

Centers For Disease Control and Prevention

Cleared 2026-10-07

Registered with
  • US (FDA)
NeuroDR

Deep Reasoning Ai, Inc.

Cleared 2026-10-07

Registered with
  • US (FDA)
Ligence Heart

UAB "Ligence"

Cleared 2026-10-07

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401)

Zhongshan GL Electronics Co, Ltd

Cleared 2026-10-07

Registered with
  • US (FDA)
Normatec Elite Heat (PRO26-SH);Normatec Elite Heat (PRO26-ST);Normatec Elite Heat (PRO26-TL);Normatec Elite Heat (PRO26-PH);Normatec Elite Heat (PRO26-PS);Normatec Elite Heat (PRO26-PT)

Normatec Industries, LP

Cleared 2026-10-06

Registered with
  • US (FDA)
MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging Bulk Package Transfer Spike

Bayer Medical Care Inc

Cleared 2026-10-06

Registered with
  • US (FDA)
LOBO Vascular Occlusion System

Okami Medical

Cleared 2026-10-06

Registered with
  • US (FDA)
TSK OptiXion

TSK Laboratory, Japan

Cleared 2026-10-06

Registered with
  • US (FDA)
OpenFlo Urinary Catheter

Urolution Medical, Inc.

Cleared 2026-10-06

Registered with
  • US (FDA)
Power Wheelchair (DC12)

Anhui Jbh Medical Apparatus Co., Ltd.

Cleared 2026-10-06

Registered with
  • US (FDA)
Forza

True Function Laboratory, Inc.

Cleared 2026-10-06

Registered with
  • US (FDA)
APRO 88 Catheter

Alembic, LLC

Cleared 2026-10-06

Registered with
  • US (FDA)
Power Wheelchair (D60)

Anhui Jbh Medical Apparatus Co., Ltd.

Cleared 2026-10-06

Registered with
  • US (FDA)
RT Elements, 4.6

Brainlab SE

Cleared 2026-10-05

Registered with
  • US (FDA)
  • EU (EUDAMED)
InkSpace Imaging Small Body Array (SBA12PH15x)

Inkspace Imaging, Inc.

Cleared 2026-10-05

Registered with
  • US (FDA)
Glucommander

Glytec, LLC

Cleared 2026-10-05

Registered with
  • US (FDA)
UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35)

Shijiazhuang Recovery Star Medical Device Co., Ltd.

Cleared 2026-10-05

Registered with
  • US (FDA)
QGuideCT (1.0)

MEDIS MEDICAL IMAGING SYSTEMS B.V.

Cleared 2026-10-05

Registered with
  • US (FDA)
Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1, ACM-5C2, ACM-5C3, ACM-5C4, ACM-5C5, ACM-5C6, ACM-5C7, ACM-5C8, ACM-5C9)

Sichuan Qianli-Beoka Medical Technology, Inc.

Cleared 2026-10-05

Registered with
  • US (FDA)
MyoVista wavECG (DG-200-B15-003)

HeartSciences, Inc.

Cleared 2026-10-05

Registered with
  • US (FDA)