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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.

3,664 devices · when each source was last refreshed

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

Device
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)
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)
ACCULINK CAROTID STENT SYSTEM

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)
ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)

Livsmed, Inc.

Cleared 2025-10-21

Registered with
  • US (FDA)
brAIn™ Shoulder Positioning

Avatar Medical

Cleared 2025-10-20

Registered with
  • US (FDA)
Q-Switched Nd: YAG Laser machine (LFS-C13U)

Sanhe Lefis Electronics Co., Ltd.

Cleared 2025-10-20

Registered with
  • US (FDA)
A8 INTEGR8™ Porous Pedicle Screws

Allumin8, Inc.

Cleared 2025-10-20

Registered with
  • US (FDA)
Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)

Vascular Flow Technologies, Ltd.

Cleared 2025-10-20

Registered with
  • US (FDA)
Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)

Feeltech Co., Ltd.

Cleared 2025-10-20

Registered with
  • US (FDA)
InkSpace Imaging Small Body Array (SBA12PH30x)

Inkspace Imaging, Inc.

Cleared 2025-10-20

Registered with
  • US (FDA)
VereSee Optical Veres Needle and Endoscopic Camera

Freyja Healthcare, LLC

Cleared 2025-10-20

Registered with
  • US (FDA)
AVAVA™ Skin Treatment System

Avava, Inc.

Cleared 2025-10-20

Registered with
  • US (FDA)
  • Canada (Health Canada)
Remi Custom Night Guard

Remi

Cleared 2025-10-17

Registered with
  • US (FDA)
StealthStation S8 Spine Software

Medtronic Navigation Inc

Cleared 2025-10-17

Registered with
  • US (FDA)
  • AU (TGA)
Program insite® Powder-Free, Disposable Nitrile Exam Gloves

Program Insite, LLC

Cleared 2025-10-17

Registered with
  • US (FDA)
Atellica IM Anti-HBe2 (aHBe2)

Siemens Healthcare Diagnostics

Cleared 2025-10-17

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