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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
BOSS

MedPark Co., Ltd.

Cleared 2026-06-16

Registered with
  • US (FDA)
  • EU (EUDAMED)
Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)

Zdeer Technology (Henan) Co., Ltd.

Cleared 2026-06-16

Registered with
  • US (FDA)
LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)

SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD.

Cleared 2026-06-16

Registered with
  • US (FDA)
NEUROMARK System (NMK00301)

Neurent Medical

Cleared 2026-06-16

Registered with
  • US (FDA)
Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)

Hubei Yjt Technology Co.,Ltd

Cleared 2026-06-16

Registered with
  • US (FDA)
Prophecy Incompass Surgical Planning System

Wright Medical Technology, Inc. (Stryker)

Cleared 2026-06-16

Registered with
  • US (FDA)
KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)

Hunan Ruijiong Biotech Co., Ltd.

Cleared 2026-06-16

Registered with
  • US (FDA)
FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T

FUJIFILM Corporation

Cleared 2026-06-16

Registered with
  • US (FDA)
myAblation Guide (VC10A)

Siemens Healthcare GmbH

Cleared 2026-06-16

Registered with
  • US (FDA)
cobas® HPV

Roche Molecular Systems, Inc.

Cleared 2026-06-16

Registered with
  • US (FDA)
  • Canada (Health Canada)
VicorderCS (VCS-SYS-1100)

80 Beats Medical GmbH

Cleared 2026-06-16

Registered with
  • US (FDA)
TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)

Hivox Biotek, Inc.

Cleared 2026-06-16

Registered with
  • US (FDA)
I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L

ITS GmbH

Cleared 2026-06-16

Registered with
  • US (FDA)
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

W. L. Gore and Associates, Inc.

Cleared 2026-06-16

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
  • EU (EUDAMED)
DRE Duo

Jpi Healthcare Co, Ltd.

Cleared 2026-06-15

Registered with
  • US (FDA)
WatchMate Software

Anumana, Inc.

Cleared 2026-06-15

Registered with
  • US (FDA)
Electric Wheelchair (S500-6)

Zhongshan Sulenz Intelligent Technology Co, LTD

Cleared 2026-06-15

Registered with
  • US (FDA)
Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)

Tournicare Pty, Ltd.

Cleared 2026-06-15

Registered with
  • US (FDA)
Neodent Scannable Healing Abutment

Jjgc Industria E Comercio DE Materiais Dentarios S.A.

Cleared 2026-06-15

Registered with
  • US (FDA)
Dynamo™ Spinal Cement; Salvo® Spine System

Spine Wave, Inc.

Cleared 2026-06-15

Registered with
  • US (FDA)
NeckTune™ 3D SA Cervical Cage

Medyssey USA, Inc.

Cleared 2026-06-15

Registered with
  • US (FDA)
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)
saypha® ChiQ™

Croma-Pharma GmbH

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)