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.

3,659 devices · when each source was last refreshed

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

Device
Mg OSTEOREVIVE™, Mg OSTEOCRETE™

Bone Solutions, Inc.

Cleared 2026-09-11

Registered with
  • US (FDA)
FINDER Flu A&B/SARS-CoV-2 Test

Baebies, Inc.

Cleared 2026-09-11

Registered with
  • US (FDA)
Vioseal X

Spident Co., Ltd.

Cleared 2026-09-11

Registered with
  • US (FDA)
Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series)

Vitaltec Corporation

Cleared 2026-09-11

Registered with
  • US (FDA)
Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System

INNO Holdings Inc. DBA Innovasis

Cleared 2026-09-11

Registered with
  • US (FDA)
PRIMED AAMI Level 3 Open Back Gowns

PRIMED MEDICAL PRODUCTS INC.

Cleared 2026-09-11

Registered with
  • US (FDA)
Potenza Prime

Jeisys Medical, Inc.

Cleared 2026-09-11

Registered with
  • US (FDA)
Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303)

Shenzhen Xinyan Medical Technology Co.,ltd.

Cleared 2026-09-11

Registered with
  • US (FDA)
Ki-67 IHC MIB-1 pharmDx (Dako Omnis)

Agilent Technologies, Inc.

Cleared 2026-09-11

Registered with
  • US (FDA)
Single Use Ureteral Access Sheath

Zhejiang Chuangxiang Medical Technology Co., Ltd.

Cleared 2026-09-11

Registered with
  • US (FDA)
  • Canada (Health Canada)
Pulsar-18 T3 Peripheral Self-Expanding Nitinol Stent System

Biotronik, GmbH & Co.

Cleared 2026-09-11

Registered with
  • US (FDA)
  • UK (MHRA)
SpineSeal Spine Sealant

Pramand, LLC

Cleared 2026-09-11

Registered with
  • US (FDA)
RENASYS DYNAFLOW Kit (66807741)

Smith & Nephew Medical, Ltd.

Cleared 2026-09-11

Registered with
  • US (FDA)
MMR IHC Panel pharmDx (Dako Omnis)

Agilent Technologies, Inc.

Cleared 2026-09-11

Registered with
  • US (FDA)
Ecomed Disposable Administration Sets

Ecomed Solutions, LLC

Cleared 2026-09-11

Registered with
  • US (FDA)
Surgical Power System

Guizhou Zirui Technology Co., Ltd.

Cleared 2026-09-11

Registered with
  • US (FDA)
CraniUS Plate

CraniUS, LLC

Cleared 2026-09-11

Registered with
  • US (FDA)
BoneVue

Curvebeam AI / Curvebeam, LLC

Cleared 2026-09-11

Registered with
  • US (FDA)
Disposable Sterile Skull Drill (LZ)

Guizhou Zirui Technology Co., Ltd.

Cleared 2026-09-11

Registered with
  • US (FDA)
CuratOR EX2742

EIZO Corporation

Cleared 2026-09-11

Registered with
  • US (FDA)
Sequential Circulator (SC-4004-DL, SC-4008-DL)

Bio Compression Systems, Inc.

Cleared 2026-09-11

Registered with
  • US (FDA)
Astron

Biotronik, GmbH & Co.

Cleared 2026-09-11

Registered with
  • US (FDA)
SpaceOAR Flex™ System

Boston Scientific Corp

Cleared 2026-09-11

Registered with
  • US (FDA)
ANTERION

Heidelberg Engineering

Cleared 2026-09-11

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
  • EU (EUDAMED)
Zephyr Endobronchial Valve (EBV) System

Pulmonx, Inc.

Cleared 2026-09-11

Registered with
  • US (FDA)
Mint ACE Pump

Beta Bionics, Inc.

Cleared 2026-09-11

Registered with
  • US (FDA)
KOWA FM-600

Kowa Company, Ltd. Chofu Factory

Cleared 2026-09-11

Registered with
  • US (FDA)
MICSI-PET

Microstructure Imaging, Inc.

Cleared 2026-09-11

Registered with
  • US (FDA)
DRIM-Nail System

41medical AG

Cleared 2026-09-11

Registered with
  • US (FDA)
iLet® Dosing Decision Software

Beta Bionics, Inc.

Cleared 2026-09-11

Registered with
  • US (FDA)
SkinSmart Antimicrobial HydroGel

Magic Science Supply, LLC

Cleared 2026-09-11

Registered with
  • US (FDA)
Shockwave™ lntravascular Lithotripsy (IVL) System with Shockwave C2 Aero Fly Coronary IVL Catheter

Shockwave Medical., Inc.

Cleared 2026-09-11

Registered with
  • US (FDA)
PureLift Pro Max

Xtreem Pulse, LLC

Cleared 2026-09-11

Registered with
  • US (FDA)
Extroducer Infusion Catheter System

SmartWise Sweden AB

Cleared 2026-09-11

Registered with
  • US (FDA)
ZBPro Diagnostic (Version 2.0)

Zbeats, Inc.

Cleared 2026-09-11

Registered with
  • US (FDA)
BioTeke® Multi-Drug Urine Test Cup

BioTeke Corporation (Wuxi) Co, Ltd

Cleared 2026-09-10

Registered with
  • US (FDA)
Geniant Cranial (Navigated Neurosurgical Positioning Robot)

KOH YOUNG TECHNOLOGY, Inc.

Cleared 2026-09-10

Registered with
  • US (FDA)
4DM

Invia

Cleared 2026-09-10

Registered with
  • US (FDA)
EVOLUTION MPX™ Total Knee System

Suzhou MicroPort OrthoRecon Co., Ltd

Cleared 2026-09-10

Registered with
  • US (FDA)
Irrigation/Urology Sets

B Braun Medical Ltd

Cleared 2026-09-10

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

Cardiva Medical, Inc.

Cleared 2026-09-10

Registered with
  • US (FDA)
Diode Laser Therapy System

Sanhe Lefis Electronics Co., Ltd.

Cleared 2026-09-10

Registered with
  • US (FDA)
Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)

Wuhan Pioon Technology Co., Ltd.

Cleared 2026-09-10

Registered with
  • US (FDA)
ACUNAV Luxera 4D ICE Catheter

Siemens Medical Solutions USA, Inc.

Cleared 2026-09-10

Registered with
  • US (FDA)
Upper Arm Blood pressure monitor (BP7155D)

Omron Healthcare, Inc.

Cleared 2026-09-10

Registered with
  • US (FDA)
TruPress

Procerus Enterprises

Cleared 2026-09-10

Registered with
  • US (FDA)
Cerasmart Forte

GC AMERICA INC.

Cleared 2026-09-10

Registered with
  • US (FDA)
Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)

Lakong Medical Devices Co., Ltd.

Cleared 2026-09-10

Registered with
  • US (FDA)
LT Antibacterial Foam with Silver Dressing

Zhejiang Longterm Medical Technology Co, Ltd

Cleared 2026-09-10

Registered with
  • US (FDA)
Quicktome Software Suite

OMNISCIENT NEUROTECHNOLOGY PTY LTD

Cleared 2026-09-10

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