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.

3,689 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
LimFlow Vector LimFlow, Inc. Cleared 2026-03-18 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	LimFlow, Inc.	2026-03-18	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
AlignRT Plus (8.0) Vision RT Limited Cleared 2026-03-18 Registered with US (FDA)	Vision RT Limited	2026-03-18	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)
Fusion FibFix Nail Fusion Orthopedics USA, LLC Cleared 2026-03-18 Registered with US (FDA)	Fusion Orthopedics USA, LLC	2026-03-18	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)
EUROPA™ Posterior Cervical Fusion Navigated Instruments Mirus, LLC Cleared 2026-03-18 Registered with US (FDA)	Mirus, LLC	2026-03-18	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)
Roche cobas BRAF V600 Mutation Test Roche Molecular Systems, Inc. Cleared 2026-03-17 Registered with US (FDA)	Roche Molecular Systems, Inc.	2026-03-17	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)
cobas EGFR Mutation Test and cobas EGFR Mutation Test v2 Roche Cleared 2026-03-17 Registered with US (FDA)	Roche	2026-03-17	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)
Electrical Scooter (SM4226) Lerado Zhongshan Peaceful Cove Business Trading Co, Ltd Cleared 2026-03-17 Registered with US (FDA)	Lerado Zhongshan Peaceful Cove Business Trading Co, Ltd	2026-03-17	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)
enCore Impression Material Encore Guards Cleared 2026-03-17 Registered with US (FDA)	Encore Guards	2026-03-17	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)
Cala kIQ Plus Cala Health, Inc. Cleared 2026-03-17 Registered with US (FDA)	Cala Health, Inc.	2026-03-17	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)
Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) C.R. Bard, Inc. Cleared 2026-03-17 Registered with US (FDA)	C.R. Bard, Inc.	2026-03-17	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)
BreathePal Bilevel (GFM50-MD2201) Compal Electronics, Inc. Cleared 2026-03-17 Registered with US (FDA)	Compal Electronics, Inc.	2026-03-17	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)
GUARDIAN™ Quick Dip Residual Chlorine (5212) Serim Research Corp. Cleared 2026-03-17 Registered with US (FDA)	Serim Research Corp.	2026-03-17	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)
Laser Thermal Therapy Kit Elesta S.P.A Cleared 2026-03-17 Registered with US (FDA) AU (TGA)	Elesta S.P.A	2026-03-17	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
MDx-Chex for BCY Streck Cleared 2026-03-17 Registered with US (FDA)	Streck	2026-03-17	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)
EchoNavigator R5.0 Philips Medical Systems Nederland BV Cleared 2026-03-17 Registered with US (FDA)	Philips Medical Systems Nederland BV	2026-03-17	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)
BTL-785NEH Btl Industries, Ltd. Cleared 2026-03-17 Registered with US (FDA)	Btl Industries, Ltd.	2026-03-17	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)
APS Spear Locking Plate A Plus Biotechnology Co., Ltd. Cleared 2026-03-17 Registered with US (FDA)	A Plus Biotechnology Co., Ltd.	2026-03-17	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)
Roche cobas® EZH2 Mutation Test Roche Molecular System, Inc. Cleared 2026-03-17 Registered with US (FDA)	Roche Molecular System, Inc.	2026-03-17	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)
Grappler Suture Anchor PCFD Tether System Paragon 28, Inc Cleared 2026-03-17 Registered with US (FDA)	Paragon 28, Inc	2026-03-17	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)
Q Pedicle Instruments K2M, Inc Cleared 2026-03-17 Registered with US (FDA)	K2M, Inc	2026-03-17	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)
Tyto Insights for Eardrum Bulging Detection Tyto Care , Ltd. Cleared 2026-03-17 Registered with US (FDA)	Tyto Care , Ltd.	2026-03-17	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)
Super Upper Limbs Versalock Plating System GM Dos Reis Industria e Comercio Ltda. Cleared 2026-03-17 Registered with US (FDA)	GM Dos Reis Industria e Comercio Ltda.	2026-03-17	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)
COBAS KRAS MUTATION TEST Roche Molecular Systems, Inc. Cleared 2026-03-17 Registered with US (FDA)	Roche Molecular Systems, Inc.	2026-03-17	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)
Stealth AXiS™ ENT clinical application Medtronic Navigation Inc Cleared 2026-03-16 Registered with US (FDA)	Medtronic Navigation Inc	2026-03-16	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)
Lifemotion Disposable Membrane Oxygenator Lifemotion Medical Technology Co., Ltd. Cleared 2026-03-16 Registered with US (FDA)	Lifemotion Medical Technology Co., Ltd.	2026-03-16	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)
DCwire Micro-guidewire Shanghai Achieva Medical Suzhou Co., Ltd. Cleared 2026-03-16 Registered with US (FDA)	Shanghai Achieva Medical Suzhou Co., Ltd.	2026-03-16	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)
Sonio Detect (v3) Sonio Cleared 2026-03-16 Registered with US (FDA)	Sonio	2026-03-16	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)
MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEM Intera Oncology, Inc. Cleared 2026-03-16 Registered with US (FDA)	Intera Oncology, Inc.	2026-03-16	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)
Healgen® Accurate Oral Fluid Drug Test Healgen Scientific, LLC Cleared 2026-03-16 Registered with US (FDA)	Healgen Scientific, LLC	2026-03-16	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)
SurgiCount+ System Stryker Instruments Cleared 2026-03-16 Registered with US (FDA)	Stryker Instruments	2026-03-16	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)
LED Light Therapy Mask (Models: T2, RLD10) Shenzhen Desida Technology Co., Ltd. Cleared 2026-03-16 Registered with US (FDA)	Shenzhen Desida Technology Co., Ltd.	2026-03-16	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)
Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) Orthocon, LLC Cleared 2026-03-16 Registered with US (FDA)	Orthocon, LLC	2026-03-16	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)
CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System CARBOFIX ORTHOPEDICS LTD. Cleared 2026-03-16 Registered with US (FDA)	CARBOFIX ORTHOPEDICS LTD.	2026-03-16	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)
Ulike Reglow Light Therapy Device (UM10) SHENZHEN ULIKE SMART ELECTRONICS CO.,LTD Cleared 2026-03-16 Registered with US (FDA)	SHENZHEN ULIKE SMART ELECTRONICS CO.,LTD	2026-03-16	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)
ZENEX Implant System_Short (R-System) Izenimplant Co.,Ltd Cleared 2026-03-16 Registered with US (FDA)	Izenimplant Co.,Ltd	2026-03-16	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)
Data Analysis Facilitation Suite (DAFS) Voronoi Health Analytics Incorporated Cleared 2026-03-16 Registered with US (FDA)	Voronoi Health Analytics Incorporated	2026-03-16	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)
APTUS Shoulder Proximal Humerus System, PentaLock 3.5 Medartis, Inc. Cleared 2026-03-16 Registered with US (FDA)	Medartis, Inc.	2026-03-16	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)
SINEFIX BAAT Medical Products B.V. Cleared 2026-03-16 Registered with US (FDA)	BAAT Medical Products B.V.	2026-03-16	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)
CGuard Prime Carotid Stent System Inspiremd, Ltd. Cleared 2026-03-16 Registered with US (FDA)	Inspiremd, Ltd.	2026-03-16	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 Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005) Technomed Europe Cleared 2026-03-15 Registered with US (FDA)	Technomed Europe	2026-03-15	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 nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) SHENZHEN KINGBOOM TECHNOLOGY CO., LTD Cleared 2026-03-13 Registered with US (FDA)	SHENZHEN KINGBOOM TECHNOLOGY CO., LTD	2026-03-13	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)
Pentacam® Cornea OCT OCULUS Optikgeräte GmbH Cleared 2026-03-13 Registered with US (FDA) UK (MHRA)	OCULUS Optikgeräte GmbH	2026-03-13	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
InferCare RECIST Beijing Infervision Healthcare Medical Technology Co., Ltd. Cleared 2026-03-13 Registered with US (FDA)	Beijing Infervision Healthcare Medical Technology Co., Ltd.	2026-03-13	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)
Embrace Neonatal MRI System Aspect Imaging, Ltd. Cleared 2026-03-13 Registered with US (FDA) Canada (Health Canada) AU (TGA)	Aspect Imaging, Ltd.	2026-03-13	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
IASIS i2 Relaxation Neurofeedback System Iasis Technologies Cleared 2026-03-13 Registered with US (FDA)	Iasis Technologies	2026-03-13	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)
Extremity CT Imaging System Mars Bioimaging , Ltd. Cleared 2026-03-13 Registered with US (FDA)	Mars Bioimaging , Ltd.	2026-03-13	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)
Access anti-HBc IgM Beckman Coulter, Inc. Cleared 2026-03-13 Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA)	Beckman Coulter, Inc.	2026-03-13	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Aeka Imaging Good Methods Global, Inc. Cleared 2026-03-13 Registered with US (FDA)	Good Methods Global, Inc.	2026-03-13	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)
SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) Pressure Products Medical Device Manufacturing, LLC Cleared 2026-03-13 Registered with US (FDA)	Pressure Products Medical Device Manufacturing, LLC	2026-03-13	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)
Permatage Flowable, Settable Bone Paste Orthocon, LLC Cleared 2026-03-13 Registered with US (FDA)	Orthocon, LLC	2026-03-13	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)