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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.

3,400 devices · when each source was last refreshed

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

Device
Aster

Osteonic Co., Ltd.

Cleared 2026-02-26

Registered with
  • US (FDA)
Owl Night Guard

Owl Dental Lab, Inc.

Cleared 2026-02-26

Registered with
  • US (FDA)
KARL STORZ ICG Imaging System with RUBINA® Lens

Karl Storz SE & CO.KG

Cleared 2026-02-26

Registered with
  • US (FDA)
Optune Lua

Novocure, GmbH

Cleared 2026-02-25

Registered with
  • US (FDA)
  • EU (EUDAMED)
Konig Bell Circumcision Clamp

Medline Industries, Inc.

Cleared 2026-02-25

Registered with
  • US (FDA)
Mako Total Knee Application

Mako Surgical Corp.

Cleared 2026-02-25

Registered with
  • US (FDA)
Remi Impression Material

Grindguard, Inc.

Cleared 2026-02-25

Registered with
  • US (FDA)
Ventana™ A Anterior Lumbar Interbody System

Spinal Elements, Inc.

Cleared 2026-02-25

Registered with
  • US (FDA)
INTEGRA ® Dermal Regeneration Template; Integra® Meshed Dermal Regeneration Template; Integra® Omnigraft Dermal Regenera

Integra Lifesciences Corp.

Cleared 2026-02-25

Registered with
  • US (FDA)
  • AU (TGA)
Electric Wheelchair

Zhejiang Yikang Medical Technology Co Ltd

Cleared 2026-02-25

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
  • EU (EUDAMED)
FIREFLY Pedicle Screw Navigation Guide

Mighty Oak Medical, Inc.

Cleared 2026-02-25

Registered with
  • US (FDA)
BD Surgiphor™ Antimicrobial Irrigation System (910110)

BECTON DICKINSON AND COMPANY (BD)

Cleared 2026-02-25

Registered with
  • US (FDA)
AMS 800™ Artificial Urinary Sphincter (AUS)

Boston Scientific Corp

Cleared 2026-02-25

Registered with
  • US (FDA)
  • AU (TGA)
Universal Seal (5-12 mm)

Intuitive Surgical, Inc.

Cleared 2026-02-24

Registered with
  • US (FDA)
Diode Laser Therapy Systems (WLA-02)

Wingderm Electro-Optics , Ltd.

Cleared 2026-02-24

Registered with
  • US (FDA)
OSTEOMNI SPINAL FIXATION SYSTEM

OSTEOMNI, Inc.

Cleared 2026-02-24

Registered with
  • US (FDA)
IntraSight Plus

Philips Image Guided Therapy Corporation

Cleared 2026-02-24

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
OSSIOfiber Suture Anchor

OSSIO , Ltd.

Cleared 2026-02-24

Registered with
  • US (FDA)
Swift Ray 1

SWIFT MEDICAL INC.

Cleared 2026-02-24

Registered with
  • US (FDA)
Electric wheelchair (W1,W3)

Shenzhen Zhimahuaerkai Technology Co, Ltd

Cleared 2026-02-24

Registered with
  • US (FDA)
XSense Cryoablation System with Cryoprobes

ICECURE MEDICAL LTD.

Cleared 2026-02-24

Registered with
  • US (FDA)
AI Platform 2.2 (AIP002)

Exo Imaging, Inc.

Cleared 2026-02-24

Registered with
  • US (FDA)
SP Electrocautery Device (SP20)

Single Pass, Inc.

Cleared 2026-02-24

Registered with
  • US (FDA)
HemoSphere Nano Monitor (HSNANO1)

Edwards Lifesciences, LLC

Cleared 2026-02-24

Registered with
  • US (FDA)
NanoPress 760A-BT (760A-BT)

Mego Afek

Cleared 2026-02-24

Registered with
  • US (FDA)
VITA VMLC Primer

VITA Zahnfabrik H Rauter GmbH & Co KG

Cleared 2026-02-23

Registered with
  • US (FDA)
MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

Siemens Shenzhen Magnetic Resonance , Ltd.

Cleared 2026-02-23

Registered with
  • US (FDA)
Duet™ Spinal Fixation System

Box Spine, LLC

Cleared 2026-02-23

Registered with
  • US (FDA)
Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)

Smart Reactors

Cleared 2026-02-23

Registered with
  • US (FDA)
LUX Expandable Lumbar Interbody System

Xenix Medical

Cleared 2026-02-23

Registered with
  • US (FDA)
Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe

Cmt Health Pte., Ltd.

Cleared 2026-02-23

Registered with
  • US (FDA)
Rubber Utility Catheter

C.R. Bard, Inc.

Cleared 2026-02-23

Registered with
  • US (FDA)
  • Canada (Health Canada)
Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)

Applied Medical Resources

Cleared 2026-02-23

Registered with
  • US (FDA)
ARCHITECT Total PSA / Alinity i Total PSA (LN 6C06/07P92)

Abbott Laboratories

Cleared 2026-02-23

Registered with
  • US (FDA)
AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)

POSKOM Co., Ltd.

Cleared 2026-02-23

Registered with
  • US (FDA)
SKIA-Head (Model: SKIA-ST00)

Skia, Inc.

Cleared 2026-02-23

Registered with
  • US (FDA)
ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial

Argon Medical Devices, Inc.

Cleared 2026-02-23

Registered with
  • US (FDA)
Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades

Philips Medical Systems Nederland BV

Cleared 2026-02-23

Registered with
  • US (FDA)
Mariana Minerva; Mariana Nimbus

ResMed PTY Ltd

Cleared 2026-02-23

Registered with
  • US (FDA)
Mobility Scooter (CL-Q3, CL-Q4)

Zhejiang Wei Ling New Energy Technology Co., Ltd.

Cleared 2026-02-23

Registered with
  • US (FDA)
IPL Hair Removal Device (Models: T31A, T32A)

SHENZHEN MLAY INTELLIGENT TECHNOLOGY CO., LTD.

Cleared 2026-02-23

Registered with
  • US (FDA)
YUWELL® Electronic Blood Pressure Monitor (YE650AR)

Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.

Cleared 2026-02-23

Registered with
  • US (FDA)
Single Use Distal Cover MAJ-2315 (MAJ-2315)

Olympus Medical Systems Corporation

Cleared 2026-02-22

Registered with
  • US (FDA)
Advanced Tissue Resection Device

Micro-Tech (Nanjing) Co., Ltd .

Cleared 2026-02-21

Registered with
  • US (FDA)
Xpert Hemorrhagic Fever

Cepheid Inc

Cleared 2026-02-20

Registered with
  • US (FDA)
KLS Martin Pure Pectus System

KLS Martin SE & Co KG

Cleared 2026-02-20

Registered with
  • US (FDA)
Disposable Ureteral Stents

Zhejiang Chuangxiang Medical Technology Co., Ltd.

Cleared 2026-02-20

Registered with
  • US (FDA)
"POINT" Kinguide Agile Hybrid Navigation System; DRF Accessories Set

Point Robotics MedTech, Inc.

Cleared 2026-02-20

Registered with
  • US (FDA)
QSCHECK UISACR

Qstag, Inc.

Cleared 2026-02-20

Registered with
  • US (FDA)
FAQ™ (LED Panel); FAQ™ (Dual LED Panel)

Foreo, Inc.

Cleared 2026-02-20

Registered with
  • US (FDA)