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.

3,665 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
LUNA 3D LAP GmbH Laser Applikationen Cleared 2026-06-04 Registered with US (FDA) UK (MHRA)	LAP GmbH Laser Applikationen	2026-06-04	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX DiaSorin, Inc. Cleared 2026-06-04 Registered with US (FDA)	DiaSorin, Inc.	2026-06-04	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)
Sonio Suspect Sonio Cleared 2026-06-04 Registered with US (FDA) EU (EUDAMED)	Sonio	2026-06-04	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) New York Embroidery Studio (NYES) Cleared 2026-06-04 Registered with US (FDA)	New York Embroidery Studio (NYES)	2026-06-04	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)
Signature ONE System Orthosoft Inc (D/B/A Zimmer Cas) Cleared 2026-06-04 Registered with US (FDA)	Orthosoft Inc (D/B/A Zimmer Cas)	2026-06-04	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)
BOND ORACLE HER2 IHC SYSTEM Leica Biosystems Cleared 2026-06-04 Registered with US (FDA)	Leica Biosystems	2026-06-04	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)
DEEPVESSEL Plaque Keya Medical Technology Co., Ltd. Cleared 2026-06-04 Registered with US (FDA)	Keya Medical Technology Co., Ltd.	2026-06-04	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)
Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form Integra Lifesciences Corp. Cleared 2026-06-04 Registered with US (FDA)	Integra Lifesciences Corp.	2026-06-04	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)
Optune Gio Novocure, GmbH Cleared 2026-06-04 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Novocure, GmbH	2026-06-04	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Radius VSM and Accessories Masimo Corp. Cleared 2026-06-04 Registered with US (FDA) AU (TGA)	Masimo Corp.	2026-06-04	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
TroKit Laparoscope Lens Wiper TroCare, LLC Cleared 2026-06-04 Registered with US (FDA)	TroCare, LLC	2026-06-04	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)
MeRT System Wave Neuroscience Cleared 2026-06-03 Registered with US (FDA)	Wave Neuroscience	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)
Alto Abdominal Stent Graft System Endologix, Inc. Cleared 2026-06-03 Registered with US (FDA) UK (MHRA)	Endologix, Inc.	2026-06-03	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
BioWave BioWraps Biowave Corporation Cleared 2026-06-03 Registered with US (FDA) AU (TGA)	Biowave Corporation	2026-06-03	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Permatage Flowable, Settable Hemostatic Bone Paste Orthocon, LLC Cleared 2026-06-03 Registered with US (FDA)	Orthocon, 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)
SteriTite Container System with MediTray Products Case Medical, Inc. Cleared 2026-06-03 Registered with US (FDA)	Case Medical, 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)
Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl S&S Glove Corporation Cleared 2026-06-03 Registered with US (FDA)	S&S Glove Corporation	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)
SIC Abutments including CAD/CAM Solutions SIC invent AG Cleared 2026-06-03 Registered with US (FDA)	SIC invent 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)
BracePaste Prime Plus American Orthodontics Cleared 2026-06-03 Registered with US (FDA) Canada (Health Canada)	American Orthodontics	2026-06-03	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
iiSure Infusion Set Deka Research & Development Corp. Cleared 2026-06-03 Registered with US (FDA)	Deka Research & Development 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)
Electric Wheelchair (DF506) Jiangsu Yveelt Medical Equipment Co., Ltd. Cleared 2026-06-03 Registered with US (FDA)	Jiangsu Yveelt 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)
Tissue Approximation System Tas Medical, Inc. Cleared 2026-06-03 Registered with US (FDA)	Tas Medical, 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 Powder 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)
KARL STORZ Endoscopic Accessories for Urology Karl Storz SE & CO.KG Cleared 2026-06-03 Registered with US (FDA)	Karl Storz SE & CO.KG	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)
HeartFocus Deski Cleared 2026-06-03 Registered with US (FDA)	Deski	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)
Esteem System Envoy Medical Corporation Cleared 2026-06-03 Registered with US (FDA)	Envoy Medical Corporation	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)
ACC STY ITM STR .016 52CM; ACC STY ITM STR .016 45CM; ACC STY ITM STR .014 58CM; ACC STY ITM STR .014 52CM; ACC STY ITM 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 Multifocal, Model ZMA00 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)
CustoMED Viewer Customed, Inc. Cleared 2026-06-03 Registered with US (FDA) EU (EUDAMED)	Customed, Inc.	2026-06-03	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
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)
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)
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)
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)