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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.

3,708 devices · when each source was last refreshed

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

Device
Impella 5.5 with SmartAssist System; Impella CP with SmartAssist System; Impella 2.5; Impella 5.0; Impella LD;

Abiomed, Inc.

Cleared 2026-06-15

Registered with
  • US (FDA)
  • AU (TGA)
Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle

Gimbo Medical Technology Shenzhen Co., Ltd.

Cleared 2026-06-15

Registered with
  • US (FDA)
LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit

DiaSorin Molecular LLC

Cleared 2026-06-15

Registered with
  • US (FDA)
VERAFEYE Imaging and Guidance System (VF-VIS-002)

Luma Vision Limited

Cleared 2026-06-15

Registered with
  • US (FDA)
Fule Interbody Fusion Cage System

Beijing Fule Science & Technology Development Co., Ltd.

Cleared 2026-06-15

Registered with
  • US (FDA)
LungMaps

Siemens Healthineers AG

Cleared 2026-06-15

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Permatage XT Settable Bone Putty

Orthocon, LLC

Cleared 2026-06-15

Registered with
  • US (FDA)
Saige-Dx

DeepHealth, Inc.

Cleared 2026-06-15

Registered with
  • US (FDA)
Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)

Zdeer Technology (Henan) Co., Ltd.

Cleared 2026-06-15

Registered with
  • US (FDA)
Curajel™ Oral Gel

USpharma, Ltd.

Cleared 2026-06-15

Registered with
  • US (FDA)
MediAI-OA

Crescom Co., Ltd.

Cleared 2026-06-15

Registered with
  • US (FDA)
Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)

Neuroelectrics Barcelona SLU

Cleared 2026-06-13

Registered with
  • US (FDA)
VENTANA PTEN (SP218) RxDx Assay

Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)

Cleared 2026-06-12

Registered with
  • US (FDA)
ThinkQA 3

Dosisoft SA

Cleared 2026-06-12

Registered with
  • US (FDA)
Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)

Polybell (Guangzhou) Limited

Cleared 2026-06-12

Registered with
  • US (FDA)
Medical Monitor (40HT513D)

Lg Electronics

Cleared 2026-06-12

Registered with
  • US (FDA)
WHILL (WHILL Model C2)

Whill, Inc.

Cleared 2026-06-12

Registered with
  • US (FDA)
Universal 1417PI

Konica Minolta Healthcare Americas, Inc.

Cleared 2026-06-12

Registered with
  • US (FDA)
MEDRAD Imaging Bulk Package Transfer Spike

Bayer Medical Care Inc

Cleared 2026-06-12

Registered with
  • US (FDA)
OneStim-DUO Cardiac Stimulator (MP5003-4CO)

Micropace Pty, Ltd.

Cleared 2026-06-12

Registered with
  • US (FDA)
Spiro-VISTA

Spiro Robotics

Cleared 2026-06-12

Registered with
  • US (FDA)
cobas pulse blood glucose monitoring system

Roche Diagnostics GmbH

Cleared 2026-06-12

Registered with
  • US (FDA)
Brainomix 360 Hyperdensity

Brainomix Limited

Cleared 2026-06-12

Registered with
  • US (FDA)
Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle

Cmt Health Pte., Ltd.

Cleared 2026-06-12

Registered with
  • US (FDA)
DYNE PORT

Dyne Medical Group, Inc.

Cleared 2026-06-12

Registered with
  • US (FDA)
Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)

Midmark Corp.

Cleared 2026-06-12

Registered with
  • US (FDA)
Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System

Stryker Corporation (Tornier, S.A.S.)

Cleared 2026-06-12

Registered with
  • US (FDA)
Cognitive Function Neuroimaging (cfNI) Software (1.0.0)

VoxNeuro, Inc.

Cleared 2026-06-12

Registered with
  • US (FDA)
BTL-899TT

Btl Industries, Ltd.

Cleared 2026-06-12

Registered with
  • US (FDA)
Virtus

Somnomed, Ltd.

Cleared 2026-06-12

Registered with
  • US (FDA)
Fast PCR Mini Respiratory Panel

Autonomous Medical Devices Incorporated

Cleared 2026-06-12

Registered with
  • US (FDA)
Exalta Proximal Tibia Plating System

Tyber Medical, LLC

Cleared 2026-06-12

Registered with
  • US (FDA)
HARBOR Occlusion Device

Nuvascular, Inc.

Cleared 2026-06-12

Registered with
  • US (FDA)
Intense Pulsed Light Therapy Device

Sanhe Lefis Electronics Co., Ltd.

Cleared 2026-06-12

Registered with
  • US (FDA)
Barbed PDO Suture

Sutura Medical Technology, Inc.

Cleared 2026-06-12

Registered with
  • US (FDA)
ADRx™ Admixture Device

Epic Medical Pte. , Ltd.

Cleared 2026-06-12

Registered with
  • US (FDA)
Disposable Blood Lancet (Soft)

Sterilance Medical(Suzhou), Inc.

Cleared 2026-06-12

Registered with
  • US (FDA)
PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)

PR Personal Care Laboratories

Cleared 2026-06-11

Registered with
  • US (FDA)
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

Mighty Oak Medical, Inc.

Cleared 2026-06-11

Registered with
  • US (FDA)
Snorbliss® Anti-Snoring Device

Endeavor Commerce, LLC

Cleared 2026-06-11

Registered with
  • US (FDA)
Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)

Shenzhen Magnet Technology Co., Ltd.

Cleared 2026-06-11

Registered with
  • US (FDA)
UNEEG EpiSight System

UNEEG medical AS

Cleared 2026-06-11

Registered with
  • US (FDA)
Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)

SMART DENTURE CONVERSIONS, LLC DBA SMART ON X, LLC

Cleared 2026-06-11

Registered with
  • US (FDA)
WRAPSODY® Cell-Impermeable Endoprosthesis

Merit Medical Systems, Inc.

Cleared 2026-06-11

Registered with
  • US (FDA)
Rosetta SM, Rosetta SP

Hass Corp.

Cleared 2026-06-11

Registered with
  • US (FDA)
MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System

Synthes USA Products, LLC

Cleared 2026-06-11

Registered with
  • US (FDA)
FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)

FloShield, Inc.

Cleared 2026-06-11

Registered with
  • US (FDA)
Verge™ Microcatheter

Instylla, Inc.

Cleared 2026-06-11

Registered with
  • US (FDA)
ICON 35; ICON 45; ICON 60; ICON 30FAF

Rehasense USA, Inc.

Cleared 2026-06-11

Registered with
  • US (FDA)
Dental X-ray System

Changzhou Boen Zhongding Medical Technology Co Ltd

Cleared 2026-06-11

Registered with
  • US (FDA)