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.

3,686 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
MIRA Surgical System Virtual Incision Cleared 2026-08-20 Registered with US (FDA)	Virtual Incision	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)
Infinity® Acute Care System (IACS) – VG8.1 Draeger Medical Systems, Inc. Cleared 2026-08-20 Registered with US (FDA)	Draeger Medical Systems, Inc.	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)
Valence InVent Xtend™ (CVG-4101-VXA) Convergence Medical Sciences , Ltd. Cleared 2026-08-20 Registered with US (FDA)	Convergence Medical Sciences , 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)
IMMULITE/IMMULITE 1000 & IMMULITE 2000 FREE PSA Siemens Medical Solutions Diagnostics Cleared 2026-08-20 Registered with US (FDA)	Siemens Medical Solutions Diagnostics	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)
Globe® Catheter and Globe® Pulsed Field System Kardium, Inc. Cleared 2026-08-20 Registered with US (FDA)	Kardium, Inc.	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)
Spiration Valve System Deployment Catheter and Loader Gyrus Acmi, Inc. Cleared 2026-08-20 Registered with US (FDA)	Gyrus Acmi, Inc.	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)
SCALA® TL Spineart Cleared 2026-08-20 Registered with US (FDA)	Spineart	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)
CPETWise Platform Medibyt , Ltd. Cleared 2026-08-20 Registered with US (FDA)	Medibyt , 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)
HardyDisk AST Tebipenem 10µg (TBP10) Hardy Diagnostics Cleared 2026-08-20 Registered with US (FDA)	Hardy Diagnostics	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)
Qoramatic Automated Stool Management Cm Technologies, Inc. Cleared 2026-08-20 Registered with US (FDA)	Cm Technologies, Inc.	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)
Remex Spine Surgery Navigation - Universal Instruments Remex Medical Corporation Cleared 2026-08-20 Registered with US (FDA)	Remex Medical Corporation	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)
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)
IMMULITE 2500 PSA, IMMULITE 2500 THIRD GENERATION PSA Siemens Healthcare Diagnostics Cleared 2026-08-20 Registered with US (FDA)	Siemens Healthcare Diagnostics	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)
IMMULITE 2000 AFP Siemens Healthcare Diagnostics Cleared 2026-08-20 Registered with US (FDA)	Siemens Healthcare Diagnostics	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)
HeartMate 3™ Left Ventricular Assist System (LVAS) Abbott Medical Cleared 2026-08-20 Registered with US (FDA)	Abbott Medical	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)
QDOT MICRO Uni-Directional Navigation Catheter Biosense Webster, Inc. Cleared 2026-08-17 Registered with US (FDA)	Biosense Webster, Inc.	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)