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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.

3,665 devices · when each source was last refreshed

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

Device
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Bloomden Bioceramics (Hunan) Co., Ltd.

Cleared 2026-03-30

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System

Spectrum Spine, LLC

Cleared 2026-03-30

Registered with
  • US (FDA)
IntelliVue Measurement Rack 6000 (867317)

Philips Medizin Systeme Boblingen GmbH

Cleared 2026-03-30

Registered with
  • US (FDA)
Sagami Original 002 Polyurethane Male Condom

MAYER LABORATORIES INC.

Cleared 2026-03-30

Registered with
  • US (FDA)
FLOW FLEXTEND Wand (72290039)

Arthrocare Corp.

Cleared 2026-03-30

Registered with
  • US (FDA)
AiORTA - Plan v2.0

ViTAA Medical Solutions, Inc.

Cleared 2026-03-30

Registered with
  • US (FDA)
CO2 Laser System

Sanhe Meditech Co.,Ltd

Cleared 2026-03-28

Registered with
  • US (FDA)
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)

Anumana, Inc.

Cleared 2026-03-28

Registered with
  • US (FDA)
ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)

ANEUVO

Cleared 2026-03-27

Registered with
  • US (FDA)
EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

Cleared 2026-03-27

Registered with
  • US (FDA)
GPA (hexafocon A) Rigid Gas Permeable Contact Lenses

Zhuhai Fitlens Medical Technology Co Ltd

Cleared 2026-03-27

Registered with
  • US (FDA)
Contour ProtégéAI+

Mim Software, Inc.

Cleared 2026-03-27

Registered with
  • US (FDA)
  • EU (EUDAMED)
Asurys Fluid Management System

Boston Scientific Corp

Cleared 2026-03-27

Registered with
  • US (FDA)
  • Canada (Health Canada)
VyPlate Anterior Cervical Plate System

Vy Spine, LLC

Cleared 2026-03-27

Registered with
  • US (FDA)
SYMPHONY Navigation Ready Instruments

MEDOS INTERNATIONAL SARL

Cleared 2026-03-27

Registered with
  • US (FDA)
Electrically Powered Wheelchair (Model YC-01)

Yurob Rehabilitation Medical Co, Ltd

Cleared 2026-03-27

Registered with
  • US (FDA)
Synergy Disc Instruments

Synergy Spine Solutions Inc

Cleared 2026-03-27

Registered with
  • US (FDA)
Ryurei

Terumo Corp.

Cleared 2026-03-27

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
Strauss Surgical cystoscope, hysteroscope and accessories Instruments

AMERICAN MEDICAL ENDOSCOPY, INC.

Cleared 2026-03-27

Registered with
  • US (FDA)
AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)

Aventix Medical, Inc.

Cleared 2026-03-27

Registered with
  • US (FDA)
Butterfly Gestational Age Tool

Butterfly Network, Inc.

Cleared 2026-03-27

Registered with
  • US (FDA)
Automated Aortic Stenosis Software (AutoAS)

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Cleared 2026-03-27

Registered with
  • US (FDA)
MedCAD® AccuStride™ System

Medcad

Cleared 2026-03-27

Registered with
  • US (FDA)
STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device

ETHICON LLC

Cleared 2026-03-27

Registered with
  • US (FDA)
SF Push- in Anchor

Surgical Fusion Technologies GmbH

Cleared 2026-03-27

Registered with
  • US (FDA)
CyClean Cord

SS Global

Cleared 2026-03-27

Registered with
  • US (FDA)
  • EU (EUDAMED)
Power wheelchair (ZS-EW8026)

Ningbo Zhishan Medical Technology Co, Ltd

Cleared 2026-03-27

Registered with
  • US (FDA)
S-scan Open (100001800)

Esaote, S.P.A.

Cleared 2026-03-27

Registered with
  • US (FDA)
Electric Wheelchair

Foshan Dahao Medical Technology Co., Ltd.

Cleared 2026-03-27

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
SportLinc Syndesmosis Device

Lincotek Medical

Cleared 2026-03-27

Registered with
  • US (FDA)
MDx-Chex for BCP

Streck

Cleared 2026-03-27

Registered with
  • US (FDA)
ARTICOR planner

Artiness S.R.L

Cleared 2026-03-27

Registered with
  • US (FDA)
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

Philips Ultrasound, Inc.

Cleared 2026-03-27

Registered with
  • US (FDA)
Spectral CT Verida Family

PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.

Cleared 2026-03-27

Registered with
  • US (FDA)
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR

Canon Medical Systems Corporation

Cleared 2026-03-27

Registered with
  • US (FDA)
OTTO™ Disinfecting Cap

ICU Medical, Inc

Cleared 2026-03-27

Registered with
  • US (FDA)
WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System

EBR Systems, Inc.

Cleared 2026-03-27

Registered with
  • US (FDA)
Real Intelligence Cori

Blue Belt Technologies, Inc.

Cleared 2026-03-26

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)

Surgify Medical OY

Cleared 2026-03-26

Registered with
  • US (FDA)
Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)

Shenzhen Urion Technology Co., Ltd.

Cleared 2026-03-26

Registered with
  • US (FDA)
Lunit INSIGHT DBT (V1.2)

Lunit, Inc.

Cleared 2026-03-26

Registered with
  • US (FDA)
Multiflex Steerable Sheath 17.5F

Vizaramed, Inc.

Cleared 2026-03-26

Registered with
  • US (FDA)
DeVilbiss 5 Liter Oxygen Concentrator (555)

DeVilbiss Healthcare LLC

Cleared 2026-03-26

Registered with
  • US (FDA)
VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)

bioMérieux SA

Cleared 2026-03-26

Registered with
  • US (FDA)
Stealth AXiS Cranial clinical application

Medtronic Navigation Inc

Cleared 2026-03-26

Registered with
  • US (FDA)
Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)

Restore Robotics

Cleared 2026-03-26

Registered with
  • US (FDA)
Zilver PTX Peripheral Drug-Eluting Stent

Cook Ireland, Ltd.

Cleared 2026-03-25

Registered with
  • US (FDA)
Invictus Bands System

Alphatec Spine, Inc.

Cleared 2026-03-25

Registered with
  • US (FDA)
MiraChlor Antimicrobial Wound Solution

Letus Corporation

Cleared 2026-03-25

Registered with
  • US (FDA)
S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)

Mevion Medical Systems

Cleared 2026-03-25

Registered with
  • US (FDA)