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	Manufacturer	Cleared	US	UK	CA	AU	EU
Dynamis Robotic Surgical System Lem Surgical AG Cleared 2026-06-20 Registered with US (FDA)	Lem Surgical AG	2026-06-20	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)
SRGC-06 GC AMERICA INC. Cleared 2026-06-18 Registered with US (FDA)	GC AMERICA 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)
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating STRYKER SUSTAINABILITY SOLUTIONS Cleared 2026-06-18 Registered with US (FDA)	STRYKER SUSTAINABILITY SOLUTIONS	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)
Pelvic Muscle Trainer (KM510, KM516B) SHENZHEN KONMED TECHNOLOGY CO., LTD. Cleared 2026-06-18 Registered with US (FDA)	SHENZHEN KONMED 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)
NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg Hycor Biomedical, Inc. Cleared 2026-06-18 Registered with US (FDA)	Hycor Biomedical, 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)
Power Wheelchair (W5915B, W5915C, W5915D) Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Cleared 2026-06-18 Registered with US (FDA)	Zhejiang Innuovo Rehabilitation Devices 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)
Syncron-E Autonomous Healthcare, Inc. Cleared 2026-06-18 Registered with US (FDA)	Autonomous Healthcare, 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)
MegaGen Zygoma Dental Implant System MegaGen Implant Co, Ltd Cleared 2026-06-18 Registered with US (FDA)	MegaGen Implant 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)
Blood Volume Analyzer (200) Daxor Corporation Cleared 2026-06-18 Registered with US (FDA)	Daxor 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)
SteriBest® Sterilization Tray System MASTEL SURGICAL INC. Cleared 2026-06-18 Registered with US (FDA)	MASTEL SURGICAL 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)
inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009); inspired™ Auto-feed Humidification Chamber (VHC10); inspired™ Auto-feed Humidification Chamber (VHC20) Vincent Healthcare Products Limited Cleared 2026-06-18 Registered with US (FDA)	Vincent Healthcare Products 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)
ZywieZ3 Sensor & Adhesive Zywie, Inc. Cleared 2026-06-18 Registered with US (FDA)	Zywie, 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)
Implantmed Plus II & Piezomed Plus II Module W&H Dentalwerk Buermoos GmbH Cleared 2026-06-18 Registered with US (FDA)	W&H Dentalwerk Buermoos GmbH	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)
Dental Implant System A.B. DENTAL DEVICES, LTD. Cleared 2026-06-18 Registered with US (FDA)	A.B. DENTAL DEVICES, 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)
TREO® Abdominal 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)
CONDUIT™ ZERO-P™ VA Secured Spacer System Avalign Technologies, Inc Cleared 2026-06-18 Registered with US (FDA)	Avalign 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)
PASCAL Precision implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS Edwards Lifesciences, LLC Cleared 2026-06-18 Registered with US (FDA)	Edwards Lifesciences, 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)
ARTHUR ROPCA Cleared 2026-06-18 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	ROPCA	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)
Vivistim Pair VNS System Mobia Medical, Inc. Cleared 2026-06-18 Registered with US (FDA)	Mobia Medical, 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)
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)
NeuroPace Remote Monitor Neuropace, Inc. Cleared 2026-06-17 Registered with US (FDA)	Neuropace, 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)
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)
AVEIR Patient Transmitter LSRM01 Abbott Medical Cleared 2026-06-17 Registered with US (FDA)	Abbott Medical	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)