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	Manufacturer	Cleared	US	UK	CA	AU	EU
Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) Micro-Energy Medical Technology Co., Ltd. Cleared 2026-06-18 Registered with US (FDA)	Micro-Energy Medical Technology 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)
InstaTRU Instant Biological Indicator for Steam (IBI-05) True Indicating, LLC Cleared 2026-06-18 Registered with US (FDA)	True Indicating, LLC	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)
LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) GUANGDONG NEWDERMO BIOTECH CO., LTD Cleared 2026-06-18 Registered with US (FDA)	GUANGDONG NEWDERMO BIOTECH 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)
AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) Suzhou AND Science &Technology Development Corp. Cleared 2026-06-18 Registered with US (FDA)	Suzhou AND Science &Technology Development Corp.	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)
MAMMOMAT B.brilliant (11372950) Siemens Medical Solutions USA, Inc. Cleared 2026-06-18 Registered with US (FDA)	Siemens Medical Solutions USA, 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)
Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) Shenzhen Root Innovation Technology Co., Ltd. Cleared 2026-06-18 Registered with US (FDA)	Shenzhen Root Innovation Technology 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)
Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe Sol-Millennium Medical Cleared 2026-06-18 Registered with US (FDA)	Sol-Millennium Medical	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)
Synapse PACS (7.6.0) Fujifilm Healthcare Americas Corporation Cleared 2026-06-18 Registered with US (FDA)	Fujifilm Healthcare Americas Corporation	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)
RadOncAI Informai Cleared 2026-06-18 Registered with US (FDA)	Informai	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)
SmartSpectra Vital Signs Monitor 1.0 Presage Security, Inc. d/b/a Presage Technologies, Inc. Cleared 2026-06-18 Registered with US (FDA)	Presage Security, Inc. d/b/a Presage Technologies, 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)
Curing Light (M-Cure 6) Guangzhou RebornEndo Medical instrument Co,. Ltd. Cleared 2026-06-18 Registered with US (FDA)	Guangzhou RebornEndo Medical instrument 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)
ECMT-100 WMD Ecm Therapeutics, Inc. Cleared 2026-06-18 Registered with US (FDA)	Ecm Therapeutics, 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)
Portable DR Imaging System Shantou Institute of Ultrasonic Instruments Co, Ltd Cleared 2026-06-18 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Shantou Institute of Ultrasonic Instruments Co, Ltd	2026-06-18	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Powder Free Nitrile Examination Gloves Non-Sterile Black KANGLONGDA VIETNAM PROTECTION TECHNOLOGY COMPANY LIMITED Cleared 2026-06-18 Registered with US (FDA)	KANGLONGDA VIETNAM PROTECTION TECHNOLOGY COMPANY LIMITED	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)
HepQuant SHUNT® Liver Diagnostic Test Hepquant, LLC Cleared 2026-06-18 Registered with US (FDA)	Hepquant, LLC	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)
aura6000™ system LivaNova USA Inc Cleared 2026-06-18 Registered with US (FDA)	LivaNova USA 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)
Wrist Blood Pressure Monitor (XW-05) Shenzhen Ziqing Medical Equipment Co., Ltd. Cleared 2026-06-18 Registered with US (FDA)	Shenzhen Ziqing Medical Equipment 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)
CORUS™ Navigation System-GN Providence Medical Technology, Inc. Cleared 2026-06-18 Registered with US (FDA)	Providence Medical Technology, 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)
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)
SURGIFLO HEMOSTATIC MATRIX KIT Ferrosan Meidcal Devices A/S Cleared 2026-06-17 Registered with US (FDA)	Ferrosan Meidcal Devices A/S	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)
Zephyr Endobronchial Valve (EBV) System Pulmonx, Inc. Cleared 2026-06-17 Registered with US (FDA)	Pulmonx, 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)
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) Canada (Health Canada) EU (EUDAMED)	Diazyme Laboratories	2026-06-16	Registered with US (FDA)	Not 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)