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
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)
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)
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) EU (EUDAMED)	Covidien	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)
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)
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)
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)
CADENCE, CADET, CONTOUR, ANGSTROM, PROFILE, PHOTON, EPIC & ATLAS ICD FAMILIES 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)
APRO 35 Swift Catheter 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)
ManaCold Compression System Manamed, Inc. Cleared 2026-08-12 Registered with US (FDA)	Manamed, 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)
EluPro Antibiotic-Eluting BioEnvelope Boston Scientific Corp Cleared 2026-08-12 Registered with US (FDA)	Boston Scientific Corp	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)
MASIMO ROOT MONITORING SYSTEM Masimo Corp. Cleared 2026-08-12 Registered with US (FDA)	Masimo Corp.	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)
Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) Hologic Inc Cleared 2026-08-12 Registered with US (FDA)	Hologic 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)
Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pulse Probe (NPA-DJ01); Probe connection line (NPA-LX-02) Hangzhou Ruidi Biotechnology Ltd. Cleared 2026-08-12 Registered with US (FDA)	Hangzhou Ruidi Biotechnology Ltd.	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)
Large Compression Screws Trimed Pvt Ltd Cleared 2026-08-12 Registered with US (FDA)	Trimed Pvt Ltd	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)
Millipede System Perfuze, Ltd. Cleared 2026-08-12 Registered with US (FDA)	Perfuze, Ltd.	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)
NeuroQuant PET Cortechs Labs, Inc. Cleared 2026-08-12 Registered with US (FDA)	Cortechs Labs, 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)
Avant (CDHFA700Q, CDHFA700T, CDHFA700D); Neutrino NxT (CDHFA800Q, CDHFA800T, CDHFA800B, CDHFA800D, CDHFA600Q, CDHFA600T, 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)
Vashe Plus Antimicrobial Solution URGO MEDICAL NORTH AMERICA, LLC Cleared 2026-08-11 Registered with US (FDA)	URGO MEDICAL NORTH AMERICA, LLC	2026-08-11	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)
Stelo Glucose Biosensor System Dexcom, Inc. Cleared 2026-08-11 Registered with US (FDA)	Dexcom, Inc.	2026-08-11	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)
VR® Personal Protective Level 4 Gown (VR Gowns) PolyConversions, Inc. Cleared 2026-08-11 Registered with US (FDA)	PolyConversions, Inc.	2026-08-11	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)
Dexter L6 System Distalmotion SA Cleared 2026-08-11 Registered with US (FDA)	Distalmotion SA	2026-08-11	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 Switched Nd:YAG Laser machine (QLQW-01) Beijing Nubway S&T Co., Ltd. Cleared 2026-08-11 Registered with US (FDA)	Beijing Nubway S&T Co., Ltd.	2026-08-11	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)
INNOVANCE® D-Dimer 2.0 (SMN 10873803) Siemens Healthcare Diagnostic Products GmbH Cleared 2026-08-11 Registered with US (FDA)	Siemens Healthcare Diagnostic Products GmbH	2026-08-11	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)
Current™ PFA Generator – TactiFlex Duo Abbott Medical Cleared 2026-08-11 Registered with US (FDA) Canada (Health Canada)	Abbott Medical	2026-08-11	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Hair Removal Device (R3C16-G Pro, R3C16-V Pro) Shenzhen Jianchao Intelligent Technology Co., Ltd. Cleared 2026-08-10 Registered with US (FDA)	Shenzhen Jianchao Intelligent Technology Co., Ltd.	2026-08-10	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)
Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A) Nova Eye Inc Cleared 2026-08-10 Registered with US (FDA)	Nova Eye Inc	2026-08-10	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)
Medtronic Evolut PRO+ Transcatheter Aortic Valve Replacement System; Medtronic Evolut FX Transcatheter Aortic Valve Repl Medtronic, Inc Cleared 2026-08-10 Registered with US (FDA)	Medtronic, Inc	2026-08-10	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)
Mobility Scooter (W3483, W3483A) Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Cleared 2026-08-10 Registered with US (FDA)	Zhejiang Innuovo Rehabilitation Devices Co.,Ltd	2026-08-10	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)