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	Manufacturer	Cleared	US	UK	CA	AU	EU
RelayPro Thoracic Stent-Graft System Bolton Medical, Inc. Cleared 2026-06-18 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Bolton Medical, Inc.	2026-06-18	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Precice™ Max System and Precice™ Ankle Salvage System Nuvasive Specialized Orthopedics, Inc. Cleared 2026-06-18 Registered with US (FDA)	Nuvasive Specialized Orthopedics, Inc.	2026-06-18	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
VIVIX-S 4386W (FXRD-4386WA) Vieworks Co., Ltd. Cleared 2026-06-18 Registered with US (FDA)	Vieworks Co., Ltd.	2026-06-18	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
3D MAC Titanium Cranial Plate (TCP) System The Surgeon General, Department of the Army (Tsg-Da) Cleared 2026-06-18 Registered with US (FDA)	The Surgeon General, Department of the Army (Tsg-Da)	2026-06-18	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
MEMO 4D Curve™ Semirigid mitral annuloplasty ring Corcym Srl Cleared 2026-06-18 Registered with US (FDA)	Corcym Srl	2026-06-18	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Vascular Assist Occlusion Triage (VAOT) (v1.0) GuideAI Health Cleared 2026-06-18 Registered with US (FDA)	GuideAI Health	2026-06-18	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
PICOSURE WORKSTATION CYNOSURE, LLC Cleared 2026-06-17 Registered with US (FDA)	CYNOSURE, LLC	2026-06-17	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
"Socko" Vimax Spinal Fixation System Socko Medical Co., Ltd. Cleared 2026-06-17 Registered with US (FDA)	Socko Medical Co., Ltd.	2026-06-17	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Amplatzer TorqVue Exchange System Abbott Medical Cleared 2026-06-17 Registered with US (FDA) Canada (Health Canada) AU (TGA)	Abbott Medical	2026-06-17	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Fule Metallic Lockable Intramedullary Nail Systems Beijing Fule Science & Technology Development Co., Ltd. Cleared 2026-06-17 Registered with US (FDA)	Beijing Fule Science & Technology Development Co., Ltd.	2026-06-17	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) Hartalega NGC Sdn. Bhd. Cleared 2026-06-17 Registered with US (FDA)	Hartalega NGC Sdn. Bhd.	2026-06-17	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Assisted Reproduction Laser System (Model ILS-400M) Hua Yue Medical Technology Co., Ltd. Cleared 2026-06-17 Registered with US (FDA)	Hua Yue Medical Technology Co., Ltd.	2026-06-17	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Non-Sterile Ultrasound Gel Sterile Ultrasound Gel Foshan Pingchuang Medical Technology Co., Ltd. Cleared 2026-06-17 Registered with US (FDA)	Foshan Pingchuang Medical Technology Co., Ltd.	2026-06-17	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Sine Monitoring Parkinson's Disease Tremor Dyskinesia Apple Watch ("SMPDTDAW") Nordic Kinetics AB Cleared 2026-06-17 Registered with US (FDA)	Nordic Kinetics AB	2026-06-17	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) Shenzhen Root Innovation Technology Co., Ltd. Cleared 2026-06-17 Registered with US (FDA)	Shenzhen Root Innovation Technology Co., Ltd.	2026-06-17	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
CoolSeal Generator® (CSL-200-90) Hologic Inc Cleared 2026-06-17 Registered with US (FDA)	Hologic Inc	2026-06-17	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Bonvadis Oneness Biotech Co., Ltd. Cleared 2026-06-17 Registered with US (FDA) EU (EUDAMED)	Oneness Biotech Co., Ltd.	2026-06-17	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
RIVOS™ EUS Access Device (M00553900) Boston Scientific Corp Cleared 2026-06-17 Registered with US (FDA)	Boston Scientific Corp	2026-06-17	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
twiist Automated Insulin Delivery (AID) System Deka Research & Development Corp. Cleared 2026-06-17 Registered with US (FDA)	Deka Research & Development Corp.	2026-06-17	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
FLEXI-PORT™ Power Injectable Implantable Port Portal Access, Inc. Cleared 2026-06-17 Registered with US (FDA)	Portal Access, Inc.	2026-06-17	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
INOSS System Inosys, Inc. Cleared 2026-06-17 Registered with US (FDA)	Inosys, Inc.	2026-06-17	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Hydro Irrigation System Stryker Instruments Cleared 2026-06-17 Registered with US (FDA)	Stryker Instruments	2026-06-17	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Portable Oxygen Concentrator Honsun(Nantong) Co., Ltd. Cleared 2026-06-17 Registered with US (FDA)	Honsun(Nantong) Co., Ltd.	2026-06-17	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Augment Off-Axis Instrument System Zimmer Inc Cleared 2026-06-16 Registered with US (FDA)	Zimmer Inc	2026-06-16	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Lipoprotein (a) Molarity Assay Diazyme Laboratories Cleared 2026-06-16 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	Diazyme Laboratories	2026-06-16	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
LimiFlex® Dynamic Sagittal Tether Instrument Set Empirical Spine, Inc. Cleared 2026-06-16 Registered with US (FDA)	Empirical Spine, Inc.	2026-06-16	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
LIPOSORBER® LA-15 System Kaneka Pharma America, LLC Cleared 2026-06-16 Registered with US (FDA)	Kaneka Pharma America, LLC	2026-06-16	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Cleared 2026-06-16 Registered with US (FDA)	Siemens Medical Solutions USA, Inc.	2026-06-16	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
HERA Interlocking Intramedullary Nailing System ZheJiang Decans Medical Devices Co., Ltd. Cleared 2026-06-16 Registered with US (FDA)	ZheJiang Decans Medical Devices Co., Ltd.	2026-06-16	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Z1 Hip System Zimmer Inc Cleared 2026-06-16 Registered with US (FDA)	Zimmer Inc	2026-06-16	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
BOSS MedPark Co., Ltd. Cleared 2026-06-16 Registered with US (FDA) EU (EUDAMED)	MedPark Co., Ltd.	2026-06-16	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with 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)	Zdeer Technology (Henan) Co., Ltd.	2026-06-16	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
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)	SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD.	2026-06-16	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
NEUROMARK System (NMK00301) Neurent Medical Cleared 2026-06-16 Registered with US (FDA)	Neurent Medical	2026-06-16	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
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)	Hubei Yjt Technology Co.,Ltd	2026-06-16	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Prophecy Incompass Surgical Planning System Wright Medical Technology, Inc. (Stryker) Cleared 2026-06-16 Registered with US (FDA)	Wright Medical Technology, Inc. (Stryker)	2026-06-16	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
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)	Hunan Ruijiong Biotech Co., Ltd.	2026-06-16	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T FUJIFILM Corporation Cleared 2026-06-16 Registered with US (FDA)	FUJIFILM Corporation	2026-06-16	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
myAblation Guide (VC10A) Siemens Healthcare GmbH Cleared 2026-06-16 Registered with US (FDA)	Siemens Healthcare GmbH	2026-06-16	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
cobas® HPV Roche Molecular Systems, Inc. Cleared 2026-06-16 Registered with US (FDA) Canada (Health Canada)	Roche Molecular Systems, Inc.	2026-06-16	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
VicorderCS (VCS-SYS-1100) 80 Beats Medical GmbH Cleared 2026-06-16 Registered with US (FDA)	80 Beats Medical GmbH	2026-06-16	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) Hivox Biotek, Inc. Cleared 2026-06-16 Registered with US (FDA)	Hivox Biotek, Inc.	2026-06-16	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
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)	ITS GmbH	2026-06-16	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
DRE Duo Jpi Healthcare Co, Ltd. Cleared 2026-06-15 Registered with US (FDA)	Jpi Healthcare Co, Ltd.	2026-06-15	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
WatchMate Software Anumana, Inc. Cleared 2026-06-15 Registered with US (FDA)	Anumana, Inc.	2026-06-15	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Electric Wheelchair (S500-6) Zhongshan Sulenz Intelligent Technology Co, LTD Cleared 2026-06-15 Registered with US (FDA)	Zhongshan Sulenz Intelligent Technology Co, LTD	2026-06-15	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) Tournicare Pty, Ltd. Cleared 2026-06-15 Registered with US (FDA)	Tournicare Pty, Ltd.	2026-06-15	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Neodent Scannable Healing Abutment Jjgc Industria E Comercio DE Materiais Dentarios S.A. Cleared 2026-06-15 Registered with US (FDA)	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	2026-06-15	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Dynamo™ Spinal Cement; Salvo® Spine System Spine Wave, Inc. Cleared 2026-06-15 Registered with US (FDA)	Spine Wave, Inc.	2026-06-15	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
NeckTune™ 3D SA Cervical Cage Medyssey USA, Inc. Cleared 2026-06-15 Registered with US (FDA)	Medyssey USA, Inc.	2026-06-15	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)