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
Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) Shanghai Waylong Intelligent Technology Co.,Ltd Cleared 2026-06-24 Registered with US (FDA)	Shanghai Waylong Intelligent Technology Co.,Ltd	2026-06-24	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)
LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus DiaSorin, Inc. Cleared 2026-06-24 Registered with US (FDA)	DiaSorin, Inc.	2026-06-24	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)
Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019 Hangzhou AGS MedTech Co., Ltd. Cleared 2026-06-24 Registered with US (FDA)	Hangzhou AGS MedTech Co., Ltd.	2026-06-24	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)
CLEAR™ Aspiration System Insera Therapeutics, Inc. Cleared 2026-06-24 Registered with US (FDA)	Insera Therapeutics, Inc.	2026-06-24	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)
Thoraflex™ Hybrid Vascutek, Ltd. Cleared 2026-06-24 Registered with US (FDA) UK (MHRA)	Vascutek, Ltd.	2026-06-24	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Concerto Versa™ Detachable Coil Medtronic, Inc Cleared 2026-06-24 Registered with US (FDA)	Medtronic, Inc	2026-06-24	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)
Microdacyn Wound Irrigation Solution Sonoma Pharmaceuticals Cleared 2026-06-24 Registered with US (FDA)	Sonoma Pharmaceuticals	2026-06-24	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)
AMSCO 700 Steam Sterilizer STERIS SAS Cleared 2026-06-24 Registered with US (FDA)	STERIS SAS	2026-06-24	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)
ConvaVAC™ Negative Pressure Wound Therapy System Convatec Limited, Gdc Building Cleared 2026-06-24 Registered with US (FDA)	Convatec Limited, Gdc Building	2026-06-24	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)
CURASYS 2 (EMDN0003) CG Bio Co., Ltd. Cleared 2026-06-23 Registered with US (FDA)	CG Bio Co., Ltd.	2026-06-23	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)
AquaBeam Robotic System Procept Biorobotics, Corporation Cleared 2026-06-23 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	Procept Biorobotics, Corporation	2026-06-23	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) Integra Lifesciences Production Corporation Cleared 2026-06-23 Registered with US (FDA)	Integra Lifesciences Production Corporation	2026-06-23	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)
Exoseal Vascular Closure Device Cordis US Corp Cleared 2026-06-23 Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA)	Cordis US Corp	2026-06-23	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Microlife Digital Peak Flow Meter, Model PF200B (PF200B) Microlife Corp. Cleared 2026-06-23 Registered with US (FDA)	Microlife Corp.	2026-06-23	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)
SCULPTRA® (injectable poly-L Lactic acid) Q-Med AB Cleared 2026-06-22 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Q-Med AB	2026-06-22	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
HeartSine® samaritan® (SAM) Public Access Defibrillator (PAD) SAM 350P, SAM 360P and SAM 450P and Accessories Heartsine Technologies, Inc. Cleared 2026-06-22 Registered with US (FDA)	Heartsine Technologies, Inc.	2026-06-22	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)
RX-1 Sleep Vivaquant, Inc. Dba Rhythm Express Cleared 2026-06-22 Registered with US (FDA)	Vivaquant, Inc. Dba Rhythm Express	2026-06-22	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)
Perfusion Measurement Platform v1 Quantified Imaging Limited Cleared 2026-06-22 Registered with US (FDA)	Quantified Imaging Limited	2026-06-22	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)
Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02) GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. Cleared 2026-06-22 Registered with US (FDA)	GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.	2026-06-22	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)
Pulsar-18 T3 Peripheral Self-Expanding Nitinol Stent System Biotronik, GmbH & Co. Cleared 2026-06-22 Registered with US (FDA) UK (MHRA)	Biotronik, GmbH & Co.	2026-06-22	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Urocross Expander System (UES-2018-C1) Prodeon Medical, Inc. Cleared 2026-06-22 Registered with US (FDA)	Prodeon Medical, Inc.	2026-06-22	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)
Manual Wheelchair (MS01);Manual Wheelchair (MA01) GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. Cleared 2026-06-22 Registered with US (FDA)	GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.	2026-06-22	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)
Fluency™ Endovascular Stent Graft Bard Peripheral Vascular Inc Cleared 2026-06-22 Registered with US (FDA) Canada (Health Canada)	Bard Peripheral Vascular Inc	2026-06-22	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Medline Reusable Blood Pressure Cuff Medline Industries, Inc. Cleared 2026-06-22 Registered with US (FDA)	Medline Industries, Inc.	2026-06-22	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)
CMN Capillary Function with Oncology Virtual Expert Cercare Medical AS Cleared 2026-06-22 Registered with US (FDA)	Cercare Medical AS	2026-06-22	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)
Flow Water-Based Personal Lubricant LBDO Group, Inc. Cleared 2026-06-22 Registered with US (FDA)	LBDO Group, Inc.	2026-06-22	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)
Astron Biotronik, GmbH & Co. Cleared 2026-06-22 Registered with US (FDA)	Biotronik, GmbH & Co.	2026-06-22	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)
DeltaNEC Interbody System Nexus Spine, LLC Cleared 2026-06-22 Registered with US (FDA)	Nexus Spine, LLC	2026-06-22	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)
LungFX™ device Lung Bioengineering, Inc. Cleared 2026-06-22 Registered with US (FDA)	Lung Bioengineering, Inc.	2026-06-22	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)
Health Line Tearaway Introducer Health Line International Corporation Cleared 2026-06-22 Registered with US (FDA)	Health Line International Corporation	2026-06-22	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)
TearView Beyond 700 Pty Ltd Cleared 2026-06-22 Registered with US (FDA) AU (TGA)	Beyond 700 Pty Ltd	2026-06-22	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
AeroPace® System Lungpacer Medical USA, Inc. Cleared 2026-06-22 Registered with US (FDA)	Lungpacer Medical USA, Inc.	2026-06-22	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)
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)
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)
MicroTransponder Vivistim Paired VNS System (Vivistim 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)