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
Bausch & Lomb SofLens® (polymacon) Contact Lenses

Bausch & Lomb Incorporated

Cleared 2025-10-24

Registered with
  • US (FDA)
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)

Olympus Medical Systems Corporation

Cleared 2025-10-24

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

AngioDynamics, Inc.

Cleared 2025-10-24

Registered with
  • US (FDA)
Hushd Pro Z-Link

Good Sleep CO Pte , Ltd.

Cleared 2025-10-24

Registered with
  • US (FDA)
CoroFlow Cardiovascular System

Coroventis Research AB

Cleared 2025-10-24

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
CD HORIZON SPINAL SYSTEM

MEDTRONIC SOFAMOR DANEK USA, INC.

Cleared 2025-10-24

Registered with
  • US (FDA)
  • AU (TGA)
Cryon-X Cold Compression

Jkh Health Co., Ltd.

Cleared 2025-10-24

Registered with
  • US (FDA)
Cocoon Solo (DX-7020s)

Dexcowin Global, Inc.

Cleared 2025-10-24

Registered with
  • US (FDA)
Medline Bag Decanter

Medline Industries, Inc.

Cleared 2025-10-24

Registered with
  • US (FDA)
ColoSense®

Geneoscopy, Inc.

Cleared 2025-10-24

Registered with
  • US (FDA)
AccuCheck

Manteia Technologies Co., Ltd.

Cleared 2025-10-24

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
  • EU (EUDAMED)
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000

Medivance, Inc.

Cleared 2025-10-24

Registered with
  • US (FDA)
COAGUCHEK XS PLUS SYSTEM

Roche Diagnostics GmbH

Cleared 2025-10-24

Registered with
  • US (FDA)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)

Hartalega NGC Sdn. Bhd.

Cleared 2025-10-23

Registered with
  • US (FDA)
Silatrix Oral Gel

Sa3, LLC

Cleared 2025-10-23

Registered with
  • US (FDA)
Picosecond Laser Device (PF131-BI)

Risu Medical Technology Co., Ltd.

Cleared 2025-10-23

Registered with
  • US (FDA)
Invisalign Palatal Expander System

Align Technology Ltd

Cleared 2025-10-23

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
MultiPulse TFL

Asclepion Laser Technologies GmbH

Cleared 2025-10-23

Registered with
  • US (FDA)
  • EU (EUDAMED)
1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)

Zhengzhou PZ Laser Slim Technology Co Limited

Cleared 2025-10-23

Registered with
  • US (FDA)
PerQseal Introducers

Vivasure Medical Limited

Cleared 2025-10-23

Registered with
  • US (FDA)
TeraRecon Cardiovascular.Calcification.CT

Terarecon,Inc.

Cleared 2025-10-23

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
UV5000W Handle

Uroviu Corporation

Cleared 2025-10-23

Registered with
  • US (FDA)
therascreen PIK3CA RGQ PCR Kit

QIAGEN GmbH

Cleared 2025-10-22

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • AU (TGA)
WELLlife COVID-19 Antigen Test Rx

Guangzhou Wondfo Biotech Co, Ltd

Cleared 2025-10-22

Registered with
  • US (FDA)
Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)

Datex-Ohmeda, Inc

Cleared 2025-10-22

Registered with
  • US (FDA)
Freedom® Total Knee System – Titan PCK Components

Maxx Orthopedics, Inc.

Cleared 2025-10-22

Registered with
  • US (FDA)
  • AU (TGA)
Mandibular Advancement Device L07

DCSTAR INC

Cleared 2025-10-22

Registered with
  • US (FDA)
electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)

Ningbo Youhe Electrical Appliance Technology Co., Ltd.

Cleared 2025-10-22

Registered with
  • US (FDA)
Absolute Pro Vascular

Abbott Vascular, Inc.

Cleared 2025-10-22

Registered with
  • US (FDA)
RX HERCULINK ELITE RENAL STENT SYSTEM

Abbott Vascular, Inc.

Cleared 2025-10-22

Registered with
  • US (FDA)
FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft Substitute

Prosidyan, Inc.

Cleared 2025-10-22

Registered with
  • US (FDA)
  • AU (TGA)
ANDI 2.0

Imeka Solutions, Inc.

Cleared 2025-10-22

Registered with
  • US (FDA)
Alegria Flash CTD Screen

Zeus Scientific, Inc.

Cleared 2025-10-22

Registered with
  • US (FDA)
XC11 ICE System, USA

Yorlabs, Inc.

Cleared 2025-10-22

Registered with
  • US (FDA)
Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)

INTERVENE GROUP LIMITED

Cleared 2025-10-22

Registered with
  • US (FDA)
RX Acculink

Abbott Vascular, Inc.

Cleared 2025-10-22

Registered with
  • US (FDA)
  • Canada (Health Canada)
SIros-X System

Genesys Spine

Cleared 2025-10-22

Registered with
  • US (FDA)
Flowflex Plus RSV + Flu A/B + COVID Home Test

Acon Laboratories, Inc.

Cleared 2025-10-22

Registered with
  • US (FDA)
Carrier XL Delivery Catheter

Balt USA, LLC

Cleared 2025-10-22

Registered with
  • US (FDA)
Sirona Advanced Imaging Suite

Sirona Medical

Cleared 2025-10-22

Registered with
  • US (FDA)
Hair Growth Laser Cap

Cosmo Far East Technology Limited

Cleared 2025-10-22

Registered with
  • US (FDA)
Pre-Sutured Tendon

Rti Surgical, Inc.

Cleared 2025-10-22

Registered with
  • US (FDA)
Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor

Simplivia Healthcare , Ltd.

Cleared 2025-10-21

Registered with
  • US (FDA)
Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)

Olympus Medical Systems Corporation

Cleared 2025-10-21

Registered with
  • US (FDA)
HemoSphere Stream Module

Edwards Lifesciences, LLC

Cleared 2025-10-21

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
NeuroAlign software

Medivis, Inc.

Cleared 2025-10-21

Registered with
  • US (FDA)
Aevumed FASE Suture Anchor

Aevumed, Inc.

Cleared 2025-10-21

Registered with
  • US (FDA)
Fine TTO™

Bodycad Laboratories, Inc.

Cleared 2025-10-21

Registered with
  • US (FDA)
Neuromuscular Transmission Monitor TOF3D (2510091)

MIPM MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN GMBH

Cleared 2025-10-21

Registered with
  • US (FDA)
TRIALTIS Spine System

MEDOS INTERNATIONAL SARL

Cleared 2025-10-21

Registered with
  • US (FDA)
  • EU (EUDAMED)