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.

3,716 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
VisuBreath Affirm Medical Technologies II, LLC Cleared 2026-07-14 Registered with US (FDA)	Affirm Medical Technologies II, LLC	2026-07-14	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)
Accoat Guide Wire SP Medical AS Cleared 2026-07-14 Registered with US (FDA) EU (EUDAMED)	SP Medical AS	2026-07-14	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System Alphatec Spine, Inc. Cleared 2026-07-14 Registered with US (FDA)	Alphatec Spine, Inc.	2026-07-14	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)
Merit MAK Nitinol/Gold-Tungsten Guide Wire Merit Medical Ireland, Ltd. Cleared 2026-07-13 Registered with US (FDA)	Merit Medical Ireland, Ltd.	2026-07-13	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)
Wearable Breast Pump (Model S32A) SHENZHEN TPH TECHNOLOGY CO., LTD. Cleared 2026-07-13 Registered with US (FDA)	SHENZHEN TPH TECHNOLOGY CO., LTD.	2026-07-13	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)
Rapid Vessel Occlusion (Rapid VO) Ischemaview, Inc. Cleared 2026-07-13 Registered with US (FDA)	Ischemaview, Inc.	2026-07-13	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)
SLIM Microcatheter Balt USA, LLC Cleared 2026-07-13 Registered with US (FDA)	Balt USA, LLC	2026-07-13	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)
Ultra-Fine™ SAFETY Insulin Syringe embecta Medical II LLC Cleared 2026-07-13 Registered with US (FDA)	embecta Medical II LLC	2026-07-13	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)
Hearing assist Meta Platform Technologies, LLC Cleared 2026-07-13 Registered with US (FDA)	Meta Platform Technologies, LLC	2026-07-13	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)
VOLNEWMER Classys, Inc. Cleared 2026-07-13 Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA) EU (EUDAMED)	Classys, Inc.	2026-07-13	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
Minitouch 3.8 Era System (Minitouch System) MicroCube LLC Cleared 2026-07-13 Registered with US (FDA)	MicroCube LLC	2026-07-13	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)
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 W. L. Gore and Associates, Inc. Cleared 2026-07-13 Registered with US (FDA) UK (MHRA) AU (TGA)	W. L. Gore and Associates, Inc.	2026-07-13	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System Boston Scientific Corp Cleared 2026-07-10 Registered with US (FDA)	Boston Scientific Corp	2026-07-10	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)
Sofia Lyme FIA; Sofia 2 Campylobacter FIA Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) Cleared 2026-07-10 Registered with US (FDA)	Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)	2026-07-10	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)
LungFlow Airway Catheter Free Flow Medical, Inc. Cleared 2026-07-10 Registered with US (FDA)	Free Flow Medical, Inc.	2026-07-10	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)
ClearSafe Closed System Medsource Labs Cleared 2026-07-10 Registered with US (FDA)	Medsource Labs	2026-07-10	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 (DY611A-2, DY612A-1) Zhejiang Lumbre Electric Appliance Co., Ltd. Cleared 2026-07-10 Registered with US (FDA)	Zhejiang Lumbre Electric Appliance Co., Ltd.	2026-07-10	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)
Capenergy C Equipments RF C200 and C400 Drakarian Capenergy Medical S.L. Cleared 2026-07-10 Registered with US (FDA)	Capenergy Medical S.L.	2026-07-10	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)
SedLine Sedation Monitor Masimo Corp. Cleared 2026-07-10 Registered with US (FDA)	Masimo Corp.	2026-07-10	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)
POSEIDON ST Signus Medinzintechnik GmbH Cleared 2026-07-10 Registered with US (FDA)	Signus Medinzintechnik GmbH	2026-07-10	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)
Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component Howmedica Osteonics Corp., Dba Stryker Orthopaedics Cleared 2026-07-10 Registered with US (FDA)	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2026-07-10	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)
Avara Viewer Avara Software Cleared 2026-07-10 Registered with US (FDA)	Avara Software	2026-07-10	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)
Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) C.R. Bard, Inc. Cleared 2026-07-10 Registered with US (FDA)	C.R. Bard, Inc.	2026-07-10	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)
AI Contouring (VA10A) Varian Medical Systems inc Cleared 2026-07-10 Registered with US (FDA)	Varian Medical Systems inc	2026-07-10	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)
Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3 Charger;Cochlear™ Osia® 3 Aqua+;Cochlear™ Osia® Fitting Software 3;Cochlear™ Osia® Smart App;Cochlear™ Osia® System Cochlear Americas Cleared 2026-07-10 Registered with US (FDA)	Cochlear Americas	2026-07-10	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)
Flowflex Plus RSV + Flu A/B + COVID Rapid Test Acon Laboratories, Inc. Cleared 2026-07-10 Registered with US (FDA)	Acon Laboratories, Inc.	2026-07-10	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)
SmartCT (R3.0 (L10)) Philips Medical Systems, Inc. Cleared 2026-07-10 Registered with US (FDA)	Philips Medical Systems, Inc.	2026-07-10	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)
NYES Tuff Cuff L3 Disposable Gowns New York Embroidery Studio Cleared 2026-07-10 Registered with US (FDA)	New York Embroidery Studio	2026-07-10	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)
Dia-Cem DiaDent Group International Cleared 2026-07-09 Registered with US (FDA)	DiaDent Group International	2026-07-09	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)
ScioCardio ECG Analysis Platform Synergen Technology Labs, LLC Cleared 2026-07-09 Registered with US (FDA)	Synergen Technology Labs, LLC	2026-07-09	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)
Millipede88 Access Catheter Perfuze, Ltd. Cleared 2026-07-09 Registered with US (FDA)	Perfuze, Ltd.	2026-07-09	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)
HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) Procept Biorobotics, Corporation Cleared 2026-07-09 Registered with US (FDA)	Procept Biorobotics, Corporation	2026-07-09	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)
Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture Teleflex Medical Sdn Bhd Cleared 2026-07-09 Registered with US (FDA)	Teleflex Medical Sdn Bhd	2026-07-09	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)
Avalus Bioprosthesis, Model 400 Medtronic, Inc Cleared 2026-07-09 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Medtronic, Inc	2026-07-09	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
SynCardia Temporary Total Artificial Heart (TAH-t) System – Freedom Driver System Syncardia Systems, LLC Cleared 2026-07-09 Registered with US (FDA)	Syncardia Systems, LLC	2026-07-09	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-Anywhere Provect.AI Cleared 2026-07-09 Registered with US (FDA)	Provect.AI	2026-07-09	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)
Lutonix™ 035 Drug Coated Balloon Catheter Lutonix Cleared 2026-07-09 Registered with US (FDA) AU (TGA)	Lutonix	2026-07-09	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
SmartGuard technology; Predictive Low Glucose technology Medtronic Minimed Cleared 2026-07-09 Registered with US (FDA)	Medtronic Minimed	2026-07-09	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)
Lava Liquid Embolic System (Lava LES) SIRTEX MEDICAL, INC. Cleared 2026-07-09 Registered with US (FDA)	SIRTEX MEDICAL, INC.	2026-07-09	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)
LifeLens Physiological Monitor Lifelens Technologies, Inc. Cleared 2026-07-09 Registered with US (FDA)	Lifelens Technologies, Inc.	2026-07-09	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)
Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) Smith & Nephew, Inc. Cleared 2026-07-09 Registered with US (FDA)	Smith & Nephew, Inc.	2026-07-09	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)
MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter Medsource Labs Cleared 2026-07-09 Registered with US (FDA)	Medsource Labs	2026-07-09	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)
Zeta TMS Navigation System Zeta Surgical Cleared 2026-07-09 Registered with US (FDA)	Zeta Surgical	2026-07-09	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)
UbiqVue™ 2AYe Cardiac System (UX2253) Lifesignals Inc Cleared 2026-07-09 Registered with US (FDA)	Lifesignals Inc	2026-07-09	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)
PINKSLIP Water-Based Personal Lubricant and Moisturizer PINKSLIP, LLC Cleared 2026-07-09 Registered with US (FDA)	PINKSLIP, LLC	2026-07-09	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)
Navitor™ Titan Valve Abbott Medical Cleared 2026-07-09 Registered with US (FDA)	Abbott Medical	2026-07-09	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)
Denture Base Resin V2 Formlabs Ohio Inc Cleared 2026-07-08 Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA) EU (EUDAMED)	Formlabs Ohio Inc	2026-07-08	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
BlueDop Vascular Expert BLUEDOP MEDICAL LTD Cleared 2026-07-08 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	BLUEDOP MEDICAL LTD	2026-07-08	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Electric wheelchair NINGBO RESSHIDI MEDICAL DEVICES CO.,LTD Cleared 2026-07-08 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	NINGBO RESSHIDI MEDICAL DEVICES CO.,LTD	2026-07-08	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Gore Excluder AAA Endoprosthesis and Gore Excluder Iliac Branch Endoprosthesis W. L. Gore and Associates, Inc. Cleared 2026-07-08 Registered with US (FDA) UK (MHRA) AU (TGA)	W. L. Gore and Associates, Inc.	2026-07-08	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)