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.

3,665 devices · when each source was last refreshed

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

Device
Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)

Tedan Surgical Innovations, LLC

Cleared 2026-04-26

Registered with
  • US (FDA)
ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System

Zsfab, Inc.

Cleared 2026-04-24

Registered with
  • US (FDA)
POYA 3.5mm Medial Proximal Tibia System

Bonebridge AG

Cleared 2026-04-24

Registered with
  • US (FDA)
PC Fix System

Chest Wall Innovations, Inc.

Cleared 2026-04-24

Registered with
  • US (FDA)
Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay

Diazyme Laboratories

Cleared 2026-04-24

Registered with
  • US (FDA)
I.T.S. PRS Phoenix II

ITS GmbH

Cleared 2026-04-24

Registered with
  • US (FDA)
Dilation Balloon Catheter

Mirco-Tech (Nanjing) Co., Ltd.

Cleared 2026-04-24

Registered with
  • US (FDA)
Amplatzer TorqVue Delivery System

Abbott GmbH

Cleared 2026-04-24

Registered with
  • US (FDA)
Visualized Access and Delivery Catheter; PB Digital Controller

Micro-Tech (Nanjing) Co., Ltd .

Cleared 2026-04-24

Registered with
  • US (FDA)
FloPatch FP120

Flosonics Medical

Cleared 2026-04-24

Registered with
  • US (FDA)
LoFric Elle Pro

Wellspect AB

Cleared 2026-04-24

Registered with
  • US (FDA)
Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute

Stryker Spine, LLC

Cleared 2026-04-24

Registered with
  • US (FDA)
EPORE® XO cup system

Implantcast GmbH

Cleared 2026-04-24

Registered with
  • US (FDA)
°M Warmer System with °M Station

Mequ A/S

Cleared 2026-04-24

Registered with
  • US (FDA)
Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403)

Applied Medical Resources

Cleared 2026-04-24

Registered with
  • US (FDA)
Vista CMS

Shanghai Draeger Medical Instrument Co., Ltd.

Cleared 2026-04-24

Registered with
  • US (FDA)
SMARTeZ™ Elastomeric Infusion Pump (RS series)

Epic Medical Pte. , Ltd.

Cleared 2026-04-24

Registered with
  • US (FDA)
OmniaSecure™ MRI SureScan™ Lead Model 3930M

Medtronic, Inc

Cleared 2026-04-24

Registered with
  • US (FDA)
ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno

Siemens Medical Solutions USA, Inc.

Cleared 2026-04-24

Registered with
  • US (FDA)
ARTISAN Myopia Models 204US1W and 206US1W

Ophtec BV

Cleared 2026-04-24

Registered with
  • US (FDA)
EdgeFlow Gel Pad

Edgecare, Inc.

Cleared 2026-04-24

Registered with
  • US (FDA)
AUTOBAHN Nailing System

Globus Medical, Inc.

Cleared 2026-04-24

Registered with
  • US (FDA)
Control-IQ+ technology

Tandem Diabetes Care, Inc.

Cleared 2026-04-24

Registered with
  • US (FDA)
Knee+

Pixee Medical

Cleared 2026-04-24

Registered with
  • US (FDA)
  • AU (TGA)
INDIGO® Aspiration System – INDIGO Link

Penumbra, Inc.

Cleared 2026-04-24

Registered with
  • US (FDA)
13C-Spirulina Gastric Emptying Breath Test (GEBT)

Advanced Breath Diagnostics

Cleared 2026-04-24

Registered with
  • US (FDA)
OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)

Abbott Medical

Cleared 2026-04-24

Registered with
  • US (FDA)
Compression Therapy Device (LGT-2202DVT)

Guangzhou Longest Medical Technology Co., Ltd.

Cleared 2026-04-24

Registered with
  • US (FDA)
Elecsys Calcitonin

Roche Diagnostics GmbH

Cleared 2026-04-24

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
LungPoint Virtual Bronchoscopic Navigation (VBN) Software

Broncus Medical, Inc

Cleared 2026-04-24

Registered with
  • US (FDA)
Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae

Medtronic, Inc

Cleared 2026-04-23

Registered with
  • US (FDA)
Liberant™ RX Aspiration Catheter

Medtronic Interventional Vascular, Inc.

Cleared 2026-04-23

Registered with
  • US (FDA)
OxyGo Portable Oxygen Concentrator (1400-7000)

Mv Life, LLC

Cleared 2026-04-23

Registered with
  • US (FDA)
Cardiva VASCADE MVP XL Venous Vascular Closure System (VVCS)

Cardiva Medical, Inc.

Cleared 2026-04-23

Registered with
  • US (FDA)
Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)

Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.

Cleared 2026-04-23

Registered with
  • US (FDA)
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)

Olympus Medical Systems Corporation

Cleared 2026-04-23

Registered with
  • US (FDA)
0.55T 12Ch Breast Coil

Neocoil

Cleared 2026-04-23

Registered with
  • US (FDA)
OptiMap Catheter - 60mm (OPTI-CATH2-60)

Cortex, Inc.

Cleared 2026-04-23

Registered with
  • US (FDA)
MANTA Vascular Closure Device

Teleflex Medical Sdn Bhd

Cleared 2026-04-23

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • AU (TGA)
ProBeam 360 Proton Therapy System v3.0

Varian Medical Systems inc

Cleared 2026-04-23

Registered with
  • US (FDA)
Freezor Cardiac Cryoablation System

Medtronic Cryocath, LP

Cleared 2026-04-23

Registered with
  • US (FDA)
ARTIS genio floor; ARTIS icono.explore floor

Siemens Medical Solutions USA, Inc.

Cleared 2026-04-23

Registered with
  • US (FDA)
CCI PACS VIEWER (PACS-US-001)

CliniComp, Intl.

Cleared 2026-04-23

Registered with
  • US (FDA)
Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)

Smwmed, Inc.

Cleared 2026-04-23

Registered with
  • US (FDA)
Tula Tympanostomy Tube Delivery Device

Tusker Medical

Cleared 2026-04-23

Registered with
  • US (FDA)
Introducer Sheath Set

Cardiocycle Medical(Suzhou) Co., Ltd.

Cleared 2026-04-23

Registered with
  • US (FDA)
Lunit INSIGHT MMG (v1.1.10)

Lunit, Inc.

Cleared 2026-04-23

Registered with
  • US (FDA)
Mobility Scooter (X-12, X-14, X-17)

Wuyi Aichi Industry & Trade Co.,Ltd.

Cleared 2026-04-22

Registered with
  • US (FDA)
Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA™ Auto-Reader (Model: 1100)

Steritec Products, Inc.

Cleared 2026-04-22

Registered with
  • US (FDA)
uOmnispace.MR

Shanghai United Imaging Healthcare Co., Ltd.

Cleared 2026-04-22

Registered with
  • US (FDA)
  • Canada (Health Canada)