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.

3,400 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
Upper arm electronic blood pressure monitor (XB-01) Shenzhen Ziqing Medical Equipment Co., Ltd. Cleared 2026-06-03 Registered with US (FDA)	Shenzhen Ziqing Medical Equipment Co., Ltd.	2026-06-03	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)
Scooter (YD-03) Yurob Rehabilitation Medical Co, Ltd Cleared 2026-06-03 Registered with US (FDA)	Yurob Rehabilitation Medical Co, Ltd	2026-06-03	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)
Straumann® ProClean™ Cassette (041.800 ; 041.801) Institut Straumann AG Cleared 2026-06-03 Registered with US (FDA)	Institut Straumann AG	2026-06-03	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)
ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE Boston Scientific Corp Cleared 2026-06-03 Registered with US (FDA)	Boston Scientific Corp	2026-06-03	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)
TECNIS™ 3-Piece Acrylic Monofocal, Model ZA9003 Johnson&Johnson Surgical Vision Inc Cleared 2026-06-03 Registered with US (FDA)	Johnson&Johnson Surgical Vision Inc	2026-06-03	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)
VSP System (Titanium Palatal Splint) 3D Systems, Inc. Cleared 2026-06-03 Registered with US (FDA)	3D Systems, Inc.	2026-06-03	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)
Roosin Collagen Dressing Roosin Medical Co, Ltd Cleared 2026-06-03 Registered with US (FDA)	Roosin Medical Co, Ltd	2026-06-03	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)
CERAMAX CERAMIC HIP SYSTEM DePuy Orthopaedics, Inc. Cleared 2026-06-03 Registered with US (FDA)	DePuy Orthopaedics, Inc.	2026-06-03	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)
Nitrile Disposable Examination Gloves Vista Industries,, LLC Cleared 2026-06-03 Registered with US (FDA)	Vista Industries,, LLC	2026-06-03	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)
CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) The Beauty Tech Group, Ltd. Cleared 2026-06-03 Registered with US (FDA)	The Beauty Tech Group, Ltd.	2026-06-03	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)
VITA Multi-Function Head Brush (TB-2343F, TB-2442F) Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. Cleared 2026-06-03 Registered with US (FDA)	Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.	2026-06-03	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™ TAVI System with Vision Technology Abbott Medical Cleared 2026-06-03 Registered with US (FDA)	Abbott Medical	2026-06-03	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)
Manual Wheelchair (LW01108) Anhui Longway Medical Technology Co, Ltd Cleared 2026-06-02 Registered with US (FDA)	Anhui Longway Medical Technology Co, Ltd	2026-06-02	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)
SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments Life Spine, LLC Cleared 2026-06-02 Registered with US (FDA)	Life Spine, LLC	2026-06-02	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)
DIAFIL DiaDent Group International Cleared 2026-06-02 Registered with US (FDA) EU (EUDAMED)	DiaDent Group International	2026-06-02	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee OrthAlign, Inc Cleared 2026-06-02 Registered with US (FDA)	OrthAlign, Inc	2026-06-02	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)
MILAN System Lumenis Be Ltd Cleared 2026-06-02 Registered with US (FDA)	Lumenis Be Ltd	2026-06-02	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)
TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems ZheJiang Decans Medical Devices Co., Ltd. Cleared 2026-06-02 Registered with US (FDA)	ZheJiang Decans Medical Devices Co., Ltd.	2026-06-02	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)
Female Culture Device; Male Culture Device; Transfer Device; Access Device Zhejiang Kindly Medical Device Co., Ltd. Cleared 2026-06-02 Registered with US (FDA)	Zhejiang Kindly Medical Device Co., Ltd.	2026-06-02	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)
Device 300419 Strip Geistlich-Pharma Cleared 2026-06-02 Registered with US (FDA)	Geistlich-Pharma	2026-06-02	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)
Pectus Blu System Biomet Microfixation Cleared 2026-06-02 Registered with US (FDA)	Biomet Microfixation	2026-06-02	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 Tone Power therapy (HiToP) (Model: HiToP PNP) Mohammadali Nezakati Cleared 2026-06-02 Registered with US (FDA)	Mohammadali Nezakati	2026-06-02	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)
Tyto Insights for Wheeze Detection (with PCCP) Tyto Care , Ltd. Cleared 2026-06-02 Registered with US (FDA)	Tyto Care , Ltd.	2026-06-02	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)
Inno-Port Disposable Bladed Trocar Taiwan Surgical Corporation Cleared 2026-06-02 Registered with US (FDA)	Taiwan Surgical Corporation	2026-06-02	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)
Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) F Care Systems USA, LLC Cleared 2026-06-02 Registered with US (FDA)	F Care Systems USA, LLC	2026-06-02	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)
Hemospray Endoscopic Hemostat (HEMO-[X]) Wilson-Cook Medical, Inc. Cleared 2026-06-02 Registered with US (FDA)	Wilson-Cook Medical, Inc.	2026-06-02	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)
DB 4000 High Impact Denture Base Carbon, Inc. Cleared 2026-06-02 Registered with US (FDA)	Carbon, Inc.	2026-06-02	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 2026-06-02 Registered with US (FDA)	Coloplast Corp.	2026-06-02	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)
Cube 4D Navigation System, VirtuEye Pro Fiagon GmbH Cleared 2026-06-02 Registered with US (FDA)	Fiagon GmbH	2026-06-02	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)
FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) FindAir Sp. z o.o. Cleared 2026-06-02 Registered with US (FDA)	FindAir Sp. z o.o.	2026-06-02	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)
Harmony™ Transcatheter Pulmonary Valve System Medtronic, Inc Cleared 2026-06-01 Registered with US (FDA) AU (TGA)	Medtronic, Inc	2026-06-01	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Medtronic CoreValve™ Evolut™ PRO Transcatheter Aortic Valve Medtronic, Inc Cleared 2026-06-01 Registered with US (FDA)	Medtronic, Inc	2026-06-01	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)
VisionAir Enhanced Stock Stent VisionAir Solutions Cleared 2026-06-01 Registered with US (FDA)	VisionAir Solutions	2026-06-01	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)
CorDx Tyfast COVID-19 Ag Rapid Test Rx CorDx, Inc. Cleared 2026-06-01 Registered with US (FDA)	CorDx, Inc.	2026-06-01	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 2026-06-01 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Medtronic, Inc	2026-06-01	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
VI°Port™ Liver Preservation System TRAFEROX TECHNOLOGIES INC. Cleared 2026-06-01 Registered with US (FDA)	TRAFEROX TECHNOLOGIES INC.	2026-06-01	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)
CardioMEMS™ HF System Abbott Medical Cleared 2026-06-01 Registered with US (FDA) AU (TGA)	Abbott Medical	2026-06-01	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
CoLink® & CoLag® Non-Sterile Screws In2bones USA, LLC Cleared 2026-05-30 Registered with US (FDA)	In2bones USA, LLC	2026-05-30	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)
Oxygen Concentrator (OX-5A, OX-5C) Oxytek Medical Technology Co, Ltd Cleared 2026-05-29 Registered with US (FDA)	Oxytek Medical Technology Co, Ltd	2026-05-29	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)
ZEUS Platform (FG0501US) iRhythm Technologies, Inc. Cleared 2026-05-29 Registered with US (FDA)	iRhythm Technologies, Inc.	2026-05-29	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)
HistoSonics® Planning Tool HistoSonics, Inc. Cleared 2026-05-29 Registered with US (FDA)	HistoSonics, Inc.	2026-05-29	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)
FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES Alcon Laboratories Cleared 2026-05-29 Registered with US (FDA)	Alcon Laboratories	2026-05-29	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)
TOPS™ System Premia Spine, Ltd. Cleared 2026-05-29 Registered with US (FDA) AU (TGA)	Premia Spine, Ltd.	2026-05-29	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
M12 Telemetry System Global Instrumentation, LLC Cleared 2026-05-29 Registered with US (FDA)	Global Instrumentation, LLC	2026-05-29	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)
BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit C.R. Bard, Inc. Cleared 2026-05-29 Registered with US (FDA)	C.R. Bard, Inc.	2026-05-29	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)
Peak Flow Meter (PF-10(BR-PEF231)) Shenzhen Bi-Rich Medical Devices Co Ltd Cleared 2026-05-29 Registered with US (FDA)	Shenzhen Bi-Rich Medical Devices Co Ltd	2026-05-29	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)
OrthoGrid Hip AI® 4.0 Orthogrid Systems, Inc. Cleared 2026-05-29 Registered with US (FDA)	Orthogrid Systems, Inc.	2026-05-29	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)
Cryo Sport 2.0 (AVA 501) Avanutri Equipamentos DE Saúde Cleared 2026-05-29 Registered with US (FDA)	Avanutri Equipamentos DE Saúde	2026-05-29	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)
LASEmaR 1500 Eufoton Srl Cleared 2026-05-29 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Eufoton Srl	2026-05-29	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Injection Needle Mirco-Tech (Nanjing) Co., Ltd. Cleared 2026-05-29 Registered with US (FDA)	Mirco-Tech (Nanjing) Co., Ltd.	2026-05-29	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)