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
Willow 24 Guidewire Arbor Endovascular, LLC Cleared 2026-03-19 Registered with US (FDA)	Arbor Endovascular, LLC	2026-03-19	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)
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens St. shine Optical Co., Ltd. Cleared 2026-03-19 Registered with US (FDA)	St. shine Optical Co., Ltd.	2026-03-19	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)
CastleLoc Pectus Bar System L&K BIOMED CO., LTD Cleared 2026-03-19 Registered with US (FDA)	L&K BIOMED CO., LTD	2026-03-19	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)
INFUSE BONE GRAFT MEDTRONIC SOFAMOR DANEK USA, INC. Cleared 2026-03-19 Registered with US (FDA) Canada (Health Canada)	MEDTRONIC SOFAMOR DANEK USA, INC.	2026-03-19	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert Senseonics, Incorporated Cleared 2026-03-19 Registered with US (FDA)	Senseonics, Incorporated	2026-03-19	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)
Enroute 0.014'' Transcarotid Guidewire Lake Region Medical Cleared 2026-03-19 Registered with US (FDA)	Lake Region Medical	2026-03-19	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)
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon Spectranetics Corp. Cleared 2026-03-19 Registered with US (FDA) EU (EUDAMED)	Spectranetics Corp.	2026-03-19	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) Wuhan PHOMED Technology Company , Ltd. Cleared 2026-03-19 Registered with US (FDA)	Wuhan PHOMED Technology Company , Ltd.	2026-03-19	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)
INFUSE BONE GRAFT Medtronic, Inc Cleared 2026-03-19 Registered with US (FDA)	Medtronic, Inc	2026-03-19	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)
DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro MedShape, Inc. Cleared 2026-03-18 Registered with US (FDA)	MedShape, Inc.	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)
HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor O&M Halyard, Inc. Cleared 2026-03-18 Registered with US (FDA)	O&M Halyard, Inc.	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)
Safety Pen Needle Ningbo Medsun Medical Co., Ltd. Cleared 2026-03-18 Registered with US (FDA) EU (EUDAMED)	Ningbo Medsun Medical Co., Ltd.	2026-03-18	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
VISUREF 600 Carl Zeiss Vision GmbH Cleared 2026-03-18 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	Carl Zeiss Vision GmbH	2026-03-18	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
syngo.via RT Image Suite VC10 Varian Medical Systems inc Cleared 2026-03-18 Registered with US (FDA)	Varian Medical Systems inc	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)
APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) Sangi Co, Ltd. Cleared 2026-03-18 Registered with US (FDA)	Sangi Co, Ltd.	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)
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)
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, v2.0 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)
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)