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.

3,659 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
Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) Guangdong Youmeng Electrical Technology Co., Ltd. Cleared 2026-08-20 Registered with US (FDA)	Guangdong Youmeng Electrical Technology Co., Ltd.	2026-08-20	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)
RefluxStop® Device and RefluxStop® Deployment Tool Implantica CE Reflux Ltd Cleared 2026-08-20 Registered with US (FDA)	Implantica CE Reflux Ltd	2026-08-20	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)
Kneu Platform (V2) Kneu Health Digital , Ltd. Cleared 2026-08-20 Registered with US (FDA)	Kneu Health Digital , Ltd.	2026-08-20	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)
EXTRON 3;EXTRON 6 Drtech Corp. Cleared 2026-08-19 Registered with US (FDA)	Drtech Corp.	2026-08-19	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)
Sprint Quattro Lead (6946M) Medtronic, Inc Cleared 2026-08-19 Registered with US (FDA) UK (MHRA) AU (TGA)	Medtronic, Inc	2026-08-19	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
BD Onclarity HPV Assay/BD COR System Becton Dickinson and Company Cleared 2026-08-19 Registered with US (FDA) AU (TGA)	Becton Dickinson and Company	2026-08-19	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Versalock Sterile Plating System GM Dos Reis Industria e Comercio Ltda. Cleared 2026-08-19 Registered with US (FDA)	GM Dos Reis Industria e Comercio Ltda.	2026-08-19	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 2026-08-19 Registered with US (FDA)	Neuropace, Inc.	2026-08-19	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)
Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US) Vitestro Cleared 2026-08-19 Registered with US (FDA)	Vitestro	2026-08-19	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)
Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK) Coopersurgical Inc., Cleared 2026-08-19 Registered with US (FDA)	Coopersurgical Inc.,	2026-08-19	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)
Swoop® Portable MR Imaging® System Hyperfine, Inc. Cleared 2026-08-19 Registered with US (FDA) UK (MHRA) AU (TGA) EU (EUDAMED)	Hyperfine, Inc.	2026-08-19	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
Pascall Sensor Unit (PSU1) Pascall Systems, Inc. Cleared 2026-08-19 Registered with US (FDA)	Pascall Systems, Inc.	2026-08-19	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)
Elecsys Phospho-Tau (217P) Plasma Roche Diagnostics GmbH Cleared 2026-08-19 Registered with US (FDA) UK (MHRA)	Roche Diagnostics GmbH	2026-08-19	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
PrecivityAD2 Test C2N Diagnostics, LLC Cleared 2026-08-19 Registered with US (FDA)	C2N Diagnostics, LLC	2026-08-19	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)
ZEROS Dental Implant System ZEROS Co., Ltd. Cleared 2026-08-19 Registered with US (FDA) EU (EUDAMED)	ZEROS Co., Ltd.	2026-08-19	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Diode Laser Therapy Systems (DL612A) Hebei Zollvan Medical Technology Co., Ltd. Cleared 2026-08-19 Registered with US (FDA)	Hebei Zollvan Medical Technology Co., Ltd.	2026-08-19	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)
ENDOFLATOR+; Smart Smoke Evacuation Karl Storz SE & CO.KG Cleared 2026-08-19 Registered with US (FDA)	Karl Storz SE & CO.KG	2026-08-19	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)
Nipro Dry Acid Concentrate Mixer Nipro Technical Solutions, Incoporated Cleared 2026-08-19 Registered with US (FDA)	Nipro Technical Solutions, Incoporated	2026-08-19	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)
ECHOLASER X4 Elesta S.P.A Cleared 2026-08-19 Registered with US (FDA)	Elesta S.P.A	2026-08-19	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)
Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN) Shokz Health Global Limited Cleared 2026-08-19 Registered with US (FDA)	Shokz Health Global Limited	2026-08-19	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)
TekBrace Solo Soft Tissue Reinforcement Device Theramicro Cleared 2026-08-18 Registered with US (FDA)	Theramicro	2026-08-18	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)
Tympendi™ (810) Grace Medical, Inc. Cleared 2026-08-18 Registered with US (FDA)	Grace Medical, Inc.	2026-08-18	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)
BluEX Cervical Expandable Cage System L&K BIOMED CO., LTD Cleared 2026-08-18 Registered with US (FDA)	L&K BIOMED CO., LTD	2026-08-18	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)
LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus DiaSorin, Inc. Cleared 2026-08-18 Registered with US (FDA)	DiaSorin, Inc.	2026-08-18	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)
Lower Limb AI (LLAI) AI Planning Logic, Inc. Cleared 2026-08-18 Registered with US (FDA)	AI Planning Logic, Inc.	2026-08-18	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)
LUOFUCON® Wound Matrix Huizhou Foryou Medical Devices Co, Ltd Cleared 2026-08-18 Registered with US (FDA)	Huizhou Foryou Medical Devices Co, Ltd	2026-08-18	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)
NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR Kossan International Sdn Bhd Cleared 2026-08-18 Registered with US (FDA)	Kossan International Sdn Bhd	2026-08-18	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)
TearCare System Sight Sciences, Inc. Cleared 2026-08-18 Registered with US (FDA)	Sight Sciences, Inc.	2026-08-18	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)
Lancing device Tianjin Huahong Technology Co, Ltd Cleared 2026-08-18 Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA) EU (EUDAMED)	Tianjin Huahong Technology Co, Ltd	2026-08-18	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
p17 XR Microcatheter Wallaby Medical, Inc. Cleared 2026-08-18 Registered with US (FDA)	Wallaby Medical, Inc.	2026-08-18	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)
HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) Axora Medical, Inc. Cleared 2026-08-18 Registered with US (FDA)	Axora Medical, Inc.	2026-08-18	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)
Senza Spiral Cord Stimulation (SCS) System Nevro Corporation Cleared 2026-08-18 Registered with US (FDA)	Nevro Corporation	2026-08-18	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)
MagicScan-1.5, GreenMR Serenity 1.5T Xingaoyi Medical Equipment Co.,Ltd Cleared 2026-08-17 Registered with US (FDA)	Xingaoyi Medical Equipment Co.,Ltd	2026-08-17	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)
Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon® Toric Aspheric Hydrophobic Acrylic Intraocular Le Alcon Laboratories Cleared 2026-08-17 Registered with US (FDA)	Alcon Laboratories	2026-08-17	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)
MySOZO Software version 6.1.0.1 (SW version 6.1.0.1) Impedimed Pty , Ltd. Cleared 2026-08-17 Registered with US (FDA)	Impedimed Pty , Ltd.	2026-08-17	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)
KBA3D (v2.4.0) S.M.A.I.O Cleared 2026-08-17 Registered with US (FDA)	S.M.A.I.O	2026-08-17	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)
Lens Optic body diameter cut Carl Zeiss Meditec Production, LLC Cleared 2026-08-17 Registered with US (FDA)	Carl Zeiss Meditec Production, LLC	2026-08-17	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)
KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions KLS Martin SE & Co KG Cleared 2026-08-17 Registered with US (FDA)	KLS Martin SE & Co KG	2026-08-17	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)
CN-Suite™ FIND Surgical Sciences Inc. D/B/A FIND Neuro Cleared 2026-08-16 Registered with US (FDA)	FIND Surgical Sciences Inc. D/B/A FIND Neuro	2026-08-16	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)
Disposable Pen Injector (KXYC-03C02, KXYC-03A03) JIANGSU ENJOSIM MEDICAL TECHNOLOGY CO., LTD. Cleared 2026-08-14 Registered with US (FDA)	JIANGSU ENJOSIM MEDICAL TECHNOLOGY CO., LTD.	2026-08-14	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)
medilogFD Schiller AG Cleared 2026-08-14 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Schiller AG	2026-08-14	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) Scivita Medical Technology Co, Ltd Cleared 2026-08-14 Registered with US (FDA)	Scivita Medical Technology Co, Ltd	2026-08-14	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)
Vital Signs Monitor (CLEO2) Infinium Medical Cleared 2026-08-14 Registered with US (FDA)	Infinium Medical	2026-08-14	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)
AdvaView ADVAHEALTH SOLUTIONS, LLC Cleared 2026-08-14 Registered with US (FDA)	ADVAHEALTH SOLUTIONS, LLC	2026-08-14	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)
EnCor EnCompass™ Breast Biopsy and Tissue Removal System Bard Peripheral Vascular Inc Cleared 2026-08-14 Registered with US (FDA)	Bard Peripheral Vascular Inc	2026-08-14	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)
AutoContour (RADAC V6) Radformation Cleared 2026-08-14 Registered with US (FDA)	Radformation	2026-08-14	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)
Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal Empatica S.R.L. Cleared 2026-08-14 Registered with US (FDA)	Empatica S.R.L.	2026-08-14	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)
52Fr ViSiGi LUX™; 52Fr ViSiGi 3D® BOEHRINGER LABORATORIES, LLC Cleared 2026-08-14 Registered with US (FDA)	BOEHRINGER LABORATORIES, LLC	2026-08-14	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)
Portable Oxygen Concentrator (PO1 5B, PO1 6B) BMC Medical Co, Ltd Cleared 2026-08-14 Registered with US (FDA)	BMC Medical Co, Ltd	2026-08-14	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)
Willow 12 Guidewire Arbor Endovascular, LLC Cleared 2026-08-14 Registered with US (FDA)	Arbor Endovascular, LLC	2026-08-14	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)