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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.

3,665 devices · when each source was last refreshed

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

Device
Disposable Radiofrequency Cannula

Abbott Medical

Cleared 2026-04-16

Registered with
  • US (FDA)
  • Canada (Health Canada)
Enso for Migraine

Hinge Health, Inc.

Cleared 2026-04-16

Registered with
  • US (FDA)
Endoflux™ Biliary & Pancreatic Stent Sets

Medi-Globe GmbH

Cleared 2026-04-16

Registered with
  • US (FDA)
Zenith Micro Guidewire

Suzhou Zenith Vascular SciTech Limited

Cleared 2026-04-16

Registered with
  • US (FDA)
ClearTip TBNA Type

Finemedix Co., Ltd.

Cleared 2026-04-16

Registered with
  • US (FDA)
ORIO-3D Cage System

Spinecraft, Inc.

Cleared 2026-04-16

Registered with
  • US (FDA)
Next Generation 088 Catheter

Balt USA, LLC

Cleared 2026-04-16

Registered with
  • US (FDA)
uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Cleared 2026-04-16

Registered with
  • US (FDA)
Insufflator (OPTO-IFL1000)

Guangdong Optomedic Technologies, Inc.

Cleared 2026-04-16

Registered with
  • US (FDA)
Redermo Wound Matrix

Beijing Kreate Medical Co., Ltd.

Cleared 2026-04-16

Registered with
  • US (FDA)
CAPSURE EPICARDIAL PACING LEAD

Medtronic, Inc

Cleared 2026-04-15

Registered with
  • US (FDA)
VERIQA RT EPID 3D

Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla

Cleared 2026-04-15

Registered with
  • US (FDA)
Refobacin Bone Cement R (110034355)

Biomet France

Cleared 2026-04-15

Registered with
  • US (FDA)
Diode Laser Therapy Systems (V19)

Weifang Mingliang Electronics Co., Ltd.

Cleared 2026-04-15

Registered with
  • US (FDA)
Uni-C Cervical Cage System

ZheJiang Decans Medical Devices Co., Ltd.

Cleared 2026-04-15

Registered with
  • US (FDA)
SureSmile Aligner (ASSY500020)

Dentsply Sirona

Cleared 2026-04-15

Registered with
  • US (FDA)
Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )

SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD.

Cleared 2026-04-15

Registered with
  • US (FDA)
REGEN Bioactive Cement

Inter-Med, Inc.

Cleared 2026-04-15

Registered with
  • US (FDA)
OPRA Implant System

Integrum AB

Cleared 2026-04-15

Registered with
  • US (FDA)
  • AU (TGA)
Clearview 3

Lenstec, Inc.

Cleared 2026-04-15

Registered with
  • US (FDA)
BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes

Becton Dickinson and Company

Cleared 2026-04-15

Registered with
  • US (FDA)
Midas Restore

Sprintray, Inc.

Cleared 2026-04-15

Registered with
  • US (FDA)
  • UK (MHRA)
Comprehensive Reverse Shoulder - HA Glenosphere Baseplates

Biomet Orthopedics, Inc.

Cleared 2026-04-15

Registered with
  • US (FDA)
CAPSURE/SP/Z NOVUS LEADS/VITATRON EXCELLENCE S+/SS+/IMPULSE/IMPULSE II LEADS

Medtronic Cardiac Rhythm Disease Management

Cleared 2026-04-15

Registered with
  • US (FDA)
Myocardial Pacing Lead

Medtronic, Inc

Cleared 2026-04-15

Registered with
  • US (FDA)
  • AU (TGA)
Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs

Lenstec, Inc.

Cleared 2026-04-15

Registered with
  • US (FDA)
STERRAD 100NX Sterilization System with ALLClear Technology (10104)

Advanced Sterilization Products

Cleared 2026-04-15

Registered with
  • US (FDA)
VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance

bioMérieux SA

Cleared 2026-04-15

Registered with
  • US (FDA)
MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM

Medtronic Cardiac Rhythm Disease Management

Cleared 2026-04-15

Registered with
  • US (FDA)
ASTar BC G- Kit

Q-Linea AB

Cleared 2026-04-15

Registered with
  • US (FDA)
  • UK (MHRA)
TRANSVENE CS/SVC LEAD

Medtronic, Inc

Cleared 2026-04-15

Registered with
  • US (FDA)
IDS-iSYS Total Testosterone

Immunodiagnostic Systems Limited

Cleared 2026-04-15

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

Crossroads Neurovascular, Inc.

Cleared 2026-04-15

Registered with
  • US (FDA)
Zilver Vena Venous Self-Expanding Stent

Cook Ireland, Ltd.

Cleared 2026-04-14

Registered with
  • US (FDA)
  • Canada (Health Canada)
HD 8Ch Wrist Array

Shenzhen RF Tech Co., Ltd.

Cleared 2026-04-14

Registered with
  • US (FDA)
  • UK (MHRA)
Inbentus Versatile

Iconic Solutions by Murcia, SL

Cleared 2026-04-14

Registered with
  • US (FDA)
TriMemo™ SEMIRIGID ANNULOPLASTY RING

Corcym Srl

Cleared 2026-04-14

Registered with
  • US (FDA)
Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)

Shenzhen Dongjiang Technology Co., Ltd.

Cleared 2026-04-14

Registered with
  • US (FDA)
SPRINT PNS System

Spr Therapeutics, LLC

Cleared 2026-04-14

Registered with
  • US (FDA)
Equinoxe® Shoulder System

Exactech, Inc.

Cleared 2026-04-14

Registered with
  • US (FDA)
ZILVER VASCULAR STENT

Cook Ireland, Ltd.

Cleared 2026-04-14

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)

Unimed Medical Supplies, Inc.

Cleared 2026-04-14

Registered with
  • US (FDA)
Critical Care Suite with Enteric Tube Positioning AI Algorithm

Ge Medical Systems, Inc.

Cleared 2026-04-14

Registered with
  • US (FDA)
Elecsys Anti-SARS-CoV-2 S

Roche Diagnostics GmbH

Cleared 2026-04-13

Registered with
  • US (FDA)
  • UK (MHRA)
b-ONE® Bipolar Head

B-One Ortho, Corp.

Cleared 2026-04-13

Registered with
  • US (FDA)
Inset Reverse Total Shoulder System

Shoulder Innovations, LLC

Cleared 2026-04-13

Registered with
  • US (FDA)
Aventus Introducer Sheath

Inquis Medical

Cleared 2026-04-13

Registered with
  • US (FDA)
Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

Zimmer Inc

Cleared 2026-04-13

Registered with
  • US (FDA)
Heal-Check Rapid COVID-19 Antigen Self-Test

Healgen Scientific, LLC

Cleared 2026-04-13

Registered with
  • US (FDA)
HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES

Hc Biologics, LLC

Cleared 2026-04-13

Registered with
  • US (FDA)