HaRi
Start Free→

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.

3,400 devices · when each source was last refreshed

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

Device
Ryurei

Terumo Corp.

Cleared 2026-03-27

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
CyClean Cord

SS GLOBAL

Cleared 2026-03-27

Registered with
  • US (FDA)
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)
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)
EluNIR™ Ridaforolimus Eluting Coronary Stent System

Medinol , Ltd.

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)
SwiftMR

Airs Medical, Inc.

Cleared 2026-03-26

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
  • EU (EUDAMED)
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)
Arterial Pressure Monitoring Set/Tray

SPECTRUM VASCULAR

Cleared 2026-03-25

Registered with
  • US (FDA)
Vortex5 Tailor's Bunion Correction System

Nvision Biomedical Technologies, LLC

Cleared 2026-03-25

Registered with
  • US (FDA)
Flex-Z™ Cervical Cage

Spinepoint, LLC

Cleared 2026-03-25

Registered with
  • US (FDA)
Airlock® Ankle Plating System

Novastep SAS

Cleared 2026-03-25

Registered with
  • US (FDA)
LYNX COBLATION Laryngeal Wand (72290254)

Arthrocare Corp.

Cleared 2026-03-25

Registered with
  • US (FDA)
Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)

Zhuhai Wesee Meditech Co., Ltd.

Cleared 2026-03-25

Registered with
  • US (FDA)
CUVIS-joint (CJ150)

CUREXO, INC.

Cleared 2026-03-25

Registered with
  • US (FDA)
Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle

Sandstone Medical (Suzhou), Inc.

Cleared 2026-03-25

Registered with
  • US (FDA)
Symplicity Spyral™ Renal Denervation Catheter

Medtronic, Inc

Cleared 2026-03-25

Registered with
  • US (FDA)
  • UK (MHRA)
Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78" Infant Circuit, HUD99060KIT / Dri-Tech with 78" Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60" Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44" Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)

Medline Industries, Inc.

Cleared 2026-03-25

Registered with
  • US (FDA)
Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)

Bausch & Lomb Incorporated

Cleared 2026-03-25

Registered with
  • US (FDA)
PRESSONE™

NIPRO MEDICAL CORPORATION

Cleared 2026-03-24

Registered with
  • US (FDA)
Electric Wheelchair (E201)

Nanjing CareMoving Rehabilitation Equipment Co, Ltd

Cleared 2026-03-24

Registered with
  • US (FDA)
Barricaid® Annular Closure Device

Intrinsic Therapeutics Incorporated

Cleared 2026-03-24

Registered with
  • US (FDA)
NanoKnife Generator (H78720300351US0)

AngioDynamics, Inc.

Cleared 2026-03-24

Registered with
  • US (FDA)