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
EnCor EnCompass™ Breast Biopsy and Tissue Removal System Bard Peripheral Vascular Inc Cleared 2025-12-12 Registered with US (FDA)	Bard Peripheral Vascular Inc	2025-12-12	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)
Fundus On Phone Non Mydriatic (FOP NM-10) Remidio Innovative Solutions Private Limited Cleared 2025-12-12 Registered with US (FDA)	Remidio Innovative Solutions Private Limited	2025-12-12	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)
iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro IHEALTH LABS INC. Cleared 2025-12-12 Registered with US (FDA)	IHEALTH LABS INC.	2025-12-12	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)
Cerynë Intimate Care Ansella Therapeutics Cleared 2025-12-12 Registered with US (FDA)	Ansella Therapeutics	2025-12-12	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)
TopCEM Vigor SA Self-Adhesive Resin Cement Rizhao Huge Biomaterials Company, Ltd. Cleared 2025-12-12 Registered with US (FDA)	Rizhao Huge Biomaterials Company, Ltd.	2025-12-12	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)
Swoop® Portable MR Imaging® System Hyperfine, Inc. Cleared 2025-12-12 Registered with US (FDA) UK (MHRA) AU (TGA) EU (EUDAMED)	Hyperfine, Inc.	2025-12-12	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro IHEALTH LABS INC. Cleared 2025-12-12 Registered with US (FDA)	IHEALTH LABS INC.	2025-12-12	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)
Self-Seal Sterilization Pouch and Roll Guangdong Maidi Medical Co., Ltd. Cleared 2025-12-12 Registered with US (FDA)	Guangdong Maidi Medical Co., Ltd.	2025-12-12	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)
Affixus® Natural Nail® Proximal Humeral System Zimmer Switzerland Manufacturing GmbH Cleared 2025-12-12 Registered with US (FDA)	Zimmer Switzerland Manufacturing GmbH	2025-12-12	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)
VaporShield Vault Paragon Group, Inc. Cleared 2025-12-12 Registered with US (FDA)	Vault Paragon Group, Inc.	2025-12-12	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)
Jason membrane Botiss Biomaterials GmbH Cleared 2025-12-12 Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA)	Botiss Biomaterials GmbH	2025-12-12	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) Eurosets Srl Cleared 2025-12-12 Registered with US (FDA)	Eurosets Srl	2025-12-12	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)
TRAUMAGEL® 2.0 Hemostatic Gel Cresilon, Inc. Cleared 2025-12-12 Registered with US (FDA)	Cresilon, Inc.	2025-12-12	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)
Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8) Micro-Energy Medical Technology Co., Ltd. Cleared 2025-12-12 Registered with US (FDA)	Micro-Energy Medical Technology Co., Ltd.	2025-12-12	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)
CogNet AI-MT+ Medcognetics, Inc. Cleared 2025-12-11 Registered with US (FDA)	Medcognetics, Inc.	2025-12-11	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)
Cervical Spine Truss System - Stand Alone (CSTS-SA) 4Web Medical, Inc. Cleared 2025-12-11 Registered with US (FDA)	4Web Medical, Inc.	2025-12-11	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)
DeepRhythmAI Medicalgorithmics SP Z.O.O. Cleared 2025-12-11 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	Medicalgorithmics SP Z.O.O.	2025-12-11	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista A Plus Biotechnology Co., Ltd. Cleared 2025-12-11 Registered with US (FDA)	A Plus Biotechnology Co., Ltd.	2025-12-11	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)
HyperFlex® Bunion Correction System Hyperflex Medical Cleared 2025-12-11 Registered with US (FDA)	Hyperflex Medical	2025-12-11	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)
TARGET DETACHABLE COIL STRYKER NEUROVASCULAR Cleared 2025-12-11 Registered with US (FDA) AU (TGA)	STRYKER NEUROVASCULAR	2025-12-11	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
MIM – LesionID Pro Mim Software, Inc. Cleared 2025-12-11 Registered with US (FDA)	Mim Software, Inc.	2025-12-11	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)
Zenflow Spring® Implant and Delivery System Zenflow, Inc. Cleared 2025-12-11 Registered with US (FDA)	Zenflow, Inc.	2025-12-11	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)
Biomedics 55 Asphere The Cooper Companies Cleared 2025-12-11 Registered with US (FDA)	The Cooper Companies	2025-12-11	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)
HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops O&M Halyard, Inc. Cleared 2025-12-11 Registered with US (FDA)	O&M Halyard, Inc.	2025-12-11	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)
ARIX Femur Nail System JEIL MEDICAL CORPORATION Cleared 2025-12-10 Registered with US (FDA)	JEIL MEDICAL CORPORATION	2025-12-10	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)
Verisafe Safety Retractable Insulin Syringes Promisemed Hangzhou Meditech Co., Ltd. Cleared 2025-12-10 Registered with US (FDA)	Promisemed Hangzhou Meditech Co., Ltd.	2025-12-10	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)
SANSA HSAT Huxley Medical Cleared 2025-12-10 Registered with US (FDA)	Huxley Medical	2025-12-10	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)
Intellidrop Brainspace, Inc. Cleared 2025-12-10 Registered with US (FDA)	Brainspace, Inc.	2025-12-10	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)
GlasIonomer FX-LC Shofu Dental Corp. Cleared 2025-12-09 Registered with US (FDA)	Shofu Dental Corp.	2025-12-09	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 Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) Guangzhou Longest Medical Technology Co., Ltd. Cleared 2025-12-09 Registered with US (FDA)	Guangzhou Longest Medical Technology Co., Ltd.	2025-12-09	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)
Focused Cryotherapy System Focused Cryo, Inc. Cleared 2025-12-09 Registered with US (FDA)	Focused Cryo, Inc.	2025-12-09	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)
INFINITT DPS INFINITT Healthcare Co, Ltd Cleared 2025-12-09 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	INFINITT Healthcare Co, Ltd	2025-12-09	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Lancing device (HH-XV-T) Tianjin Huahong Technology Co, Ltd Cleared 2025-12-09 Registered with US (FDA)	Tianjin Huahong Technology Co, Ltd	2025-12-09	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)
DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) DeVilbiss Healthcare LLC Cleared 2025-12-09 Registered with US (FDA)	DeVilbiss Healthcare LLC	2025-12-09	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)
Atlantis® Abutments in Titanium Dentsply Sirona Cleared 2025-12-09 Registered with US (FDA)	Dentsply Sirona	2025-12-09	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)
Allia Moveo Ge Medical Systems Scs Cleared 2025-12-09 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Ge Medical Systems Scs	2025-12-09	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) Guangdong Ace-Tec Co., Ltd. Cleared 2025-12-08 Registered with US (FDA)	Guangdong Ace-Tec Co., Ltd.	2025-12-08	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)
DeGen Medical Patient Specific Implant (PSI) System Degen Medical Cleared 2025-12-08 Registered with US (FDA)	Degen Medical	2025-12-08	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)
Ceribell Delirium Monitor System Ceribell, Inc. Cleared 2025-12-08 Registered with US (FDA)	Ceribell, Inc.	2025-12-08	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)
Sequential Compression System (SCD600) Shenzhen Comen Medical Instruments Co,Ltd Cleared 2025-12-08 Registered with US (FDA) AU (TGA)	Shenzhen Comen Medical Instruments Co,Ltd	2025-12-08	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
HeartBeam AIMIGo with 12-L ECG Synthesis Software System Heartbeam, Inc. Cleared 2025-12-08 Registered with US (FDA)	Heartbeam, Inc.	2025-12-08	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)
Fetal EchoScan (v1.2) Brightheart Cleared 2025-12-08 Registered with US (FDA)	Brightheart	2025-12-08	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 (DH01126) Foshan Dahao Medical Technology Co., Ltd. Cleared 2025-12-08 Registered with US (FDA)	Foshan Dahao Medical Technology Co., Ltd.	2025-12-08	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)
Glass Ceramic Shenzhen Xiangtong Co., Ltd. Cleared 2025-12-08 Registered with US (FDA) EU (EUDAMED)	Shenzhen Xiangtong Co., Ltd.	2025-12-08	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Flow FL-100 Flow Neuroscience AB Cleared 2025-12-08 Registered with US (FDA) AU (TGA)	Flow Neuroscience AB	2025-12-08	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) Karl Storz SE & CO.KG Cleared 2025-12-05 Registered with US (FDA)	Karl Storz SE & CO.KG	2025-12-05	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)
Personalized Therapy Comfort Settings (PTCS) ResMed PTY Ltd Cleared 2025-12-05 Registered with US (FDA)	ResMed PTY Ltd	2025-12-05	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 (W47) Jiangsu Jumao X-Care Medical Equipment Co.,Ltd Cleared 2025-12-05 Registered with US (FDA)	Jiangsu Jumao X-Care Medical Equipment Co.,Ltd	2025-12-05	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-Core Mediclus Co., Ltd. Cleared 2025-12-05 Registered with US (FDA) EU (EUDAMED)	Mediclus Co., Ltd.	2025-12-05	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc ) Dornier Medtech America Inc (Dmta) Cleared 2025-12-05 Registered with US (FDA)	Dornier Medtech America Inc (Dmta)	2025-12-05	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)