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
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)
Altaviva™ Medtronic Neuromodulation Cleared 2026-08-14 Registered with US (FDA)	Medtronic Neuromodulation	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)
InterStim® Therapy System Medtronic Neuromodulation Cleared 2026-08-14 Registered with US (FDA)	Medtronic Neuromodulation	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)
NC Euphora Rapid Exchange Balloon Dilatation Catheter Medtronic, Ireland Cleared 2026-08-14 Registered with US (FDA)	Medtronic, Ireland	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)
MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MF Cerenovus, Inc. Cleared 2026-08-14 Registered with US (FDA)	Cerenovus, 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)
BAGUERA® C Cervical Disc Surgical Instruments Spineart Cleared 2026-08-14 Registered with US (FDA)	Spineart	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)
Redermax Antibacterial Wound Matrix Beijing Kreate Medical Co., Ltd. Cleared 2026-08-14 Registered with US (FDA)	Beijing Kreate 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)
TruSight Oncology Comprehensive Illumina, Inc. Cleared 2026-08-14 Registered with US (FDA)	Illumina, 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)
Transpara (2.1.0) Screenpoint Medical B.V. Cleared 2026-08-14 Registered with US (FDA)	Screenpoint Medical B.V.	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)
Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent System Stent S Medtronic Vascular Cleared 2026-08-14 Registered with US (FDA)	Medtronic Vascular	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)
QuickVision Ultimate rTMS Brain Ultimate, Inc. Cleared 2026-08-14 Registered with US (FDA)	Brain Ultimate, 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)
NHanceIT IMDS Operation B.V. Cleared 2026-08-14 Registered with US (FDA)	IMDS Operation B.V.	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)
High Intensity Focused Electromagnetic Stimulation Device (FE60) Beijing Winkonlaser Technology Limited Cleared 2026-08-13 Registered with US (FDA)	Beijing Winkonlaser Technology Limited	2026-08-13	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)
AIR Recon DL Ge Medical Systems, Inc. Cleared 2026-08-13 Registered with US (FDA)	Ge Medical Systems, Inc.	2026-08-13	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)
BP Go (BPP-855) Wellvii, Inc. Cleared 2026-08-13 Registered with US (FDA)	Wellvii, Inc.	2026-08-13	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)
Paradise™ Ultrasound Renal Denervation System (Paradise System); Paradise™ Catheter Recor Medical, Inc. Cleared 2026-08-13 Registered with US (FDA)	Recor Medical, Inc.	2026-08-13	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)
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P) Joytech Healthcare Co. , Ltd. Cleared 2026-08-13 Registered with US (FDA)	Joytech Healthcare Co. , Ltd.	2026-08-13	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)
Dashboard (P007000) Hill-Rom, Inc Cleared 2026-08-13 Registered with US (FDA)	Hill-Rom, Inc	2026-08-13	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)
Any-Cem Mediclus Co., Ltd. Cleared 2026-08-13 Registered with US (FDA)	Mediclus Co., Ltd.	2026-08-13	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)
Cordella Pulmonary Artery Sensor System (CorPASS) Endotronix, Inc. Cleared 2026-08-13 Registered with US (FDA)	Endotronix, Inc.	2026-08-13	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)
Levo Gen 2 Tinnitus Therapy System Levo Medical Corporation Cleared 2026-08-13 Registered with US (FDA)	Levo Medical Corporation	2026-08-13	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)
UltraPrint Flexible Denture UV GUANGZHOU HEYGEARS IMC.INC Cleared 2026-08-13 Registered with US (FDA) EU (EUDAMED)	GUANGZHOU HEYGEARS IMC.INC	2026-08-13	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution Menicon Co, Ltd Cleared 2026-08-13 Registered with US (FDA)	Menicon Co, Ltd	2026-08-13	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)
BIS™ Advance pEEG Module Covidien Cleared 2026-08-13 Registered with US (FDA)	Covidien	2026-08-13	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)
Titan Inflatable Penile Prosthesis (IPP) Coloplast Corp. Cleared 2026-08-13 Registered with US (FDA)	Coloplast Corp.	2026-08-13	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)
VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) Freyja Healthcare, LLC Cleared 2026-08-13 Registered with US (FDA)	Freyja Healthcare, LLC	2026-08-13	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)
TrachFlush Aw Technologies Aps Cleared 2026-08-13 Registered with US (FDA) UK (MHRA) AU (TGA)	Aw Technologies Aps	2026-08-13	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
MIKRON TRAUMA BONE PLATE& SCREW SYSTEM Mikron Makina San ve Tic Ltd Şti Cleared 2026-08-13 Registered with US (FDA)	Mikron Makina San ve Tic Ltd Şti	2026-08-13	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)
CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set Cerenovus, Inc. Cleared 2026-08-13 Registered with US (FDA)	Cerenovus, Inc.	2026-08-13	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)
APRO 35 Swift Catheter and Alembic Aspiration Tubing Alembic, LLC Cleared 2026-08-12 Registered with US (FDA)	Alembic, LLC	2026-08-12	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 II Left Ventricular Assist System (LVAS) Abbott Medical Cleared 2026-08-12 Registered with US (FDA)	Abbott Medical	2026-08-12	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)
enVista Envy™ Hydrophobic Acrylic Intraocular Lens Bausch & Lomb Incorporated Cleared 2026-08-12 Registered with US (FDA)	Bausch & Lomb Incorporated	2026-08-12	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)
BA-004CC FUJIFILM Corporation Cleared 2026-08-12 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	FUJIFILM Corporation	2026-08-12	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
FoundationOne Liquid CDx (F1LCDx) Foundation Medicine, Inc. Cleared 2026-08-12 Registered with US (FDA) UK (MHRA) AU (TGA)	Foundation Medicine, Inc.	2026-08-12	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
GF-310R Multigas Unit (GF-310R) NIHON KOHDEN CORPORATION Cleared 2026-08-12 Registered with US (FDA)	NIHON KOHDEN CORPORATION	2026-08-12	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)
CadAI-B Dx BeamWorks, Inc. Cleared 2026-08-12 Registered with US (FDA)	BeamWorks, Inc.	2026-08-12	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)