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
COLOGUARD Exact Sciences Corporation Cleared 2026-06-09 Registered with US (FDA)	Exact Sciences Corporation	2026-06-09	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)
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner Materialise N.V Cleared 2026-06-09 Registered with US (FDA)	Materialise N.V	2026-06-09	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)
LD INGEVITY™ PLUS AF Boston Scientific Corp Cleared 2026-06-09 Registered with US (FDA)	Boston Scientific Corp	2026-06-09	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)
Melody Transcatheter Pulmonary Valve System, which includes the Melody Transcatheter Pulmonary Valve (Melody TPV) and th Medtronic, Inc Cleared 2026-06-09 Registered with US (FDA) Canada (Health Canada) AU (TGA)	Medtronic, Inc	2026-06-09	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Cologuard Plus™ Exact Sciences Corporation Cleared 2026-06-09 Registered with US (FDA)	Exact Sciences Corporation	2026-06-09	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)
ChanPin Pedicle Screw Spinal System Chanpin Medtak Co., Ltd. Cleared 2026-06-09 Registered with US (FDA)	Chanpin Medtak Co., Ltd.	2026-06-09	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)
ACUITY™ SPIRAL, ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L Boston Scientific Corp Cleared 2026-06-09 Registered with US (FDA)	Boston Scientific Corp	2026-06-09	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)
Lipocosm Harmonic System LIPOCOSM, LLC Cleared 2026-06-08 Registered with US (FDA)	LIPOCOSM, LLC	2026-06-08	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)
ELEOS™ with NanoCept® Technology Limb Salvage System Onkos Surgical, Inc Cleared 2026-06-08 Registered with US (FDA)	Onkos Surgical, Inc	2026-06-08	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)
EchoNext Pathwai, Inc. Cleared 2026-06-08 Registered with US (FDA)	Pathwai, Inc.	2026-06-08	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)
Virgo Mobility Scooter (Virgo-D,Virgo-F) Jiangsu Intco Medical Products Co., Ltd. Cleared 2026-06-08 Registered with US (FDA)	Jiangsu Intco Medical Products Co., Ltd.	2026-06-08	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)
2D Hip Planning Software One Ortho Cleared 2026-06-08 Registered with US (FDA)	One Ortho	2026-06-08	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)
Oncomine Dx Express Test Life Technologies Holdings Pte Ltd Cleared 2026-06-08 Registered with US (FDA)	Life Technologies Holdings Pte Ltd	2026-06-08	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)
Genio® System 2.1 Nyxoah SA Cleared 2026-06-08 Registered with US (FDA)	Nyxoah SA	2026-06-08	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)
Apollo Quattro (APQ-10M) Weero Co. Cleared 2026-06-08 Registered with US (FDA)	Weero Co.	2026-06-08	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)
Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System Dexcom, Inc. Cleared 2026-06-08 Registered with US (FDA)	Dexcom, Inc.	2026-06-08	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)
Alinity m HR HPV Assay Abbott Molecular, Inc. Cleared 2026-06-08 Registered with US (FDA)	Abbott Molecular, Inc.	2026-06-08	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)
PerClot® Polysaccharide Hemostatic System Baxter Healthcare Corp Cleared 2026-06-08 Registered with US (FDA)	Baxter Healthcare Corp	2026-06-08	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)
RxSight Light Adjustable Lens; Light Delivery Device Rxsight, Inc. Cleared 2026-06-08 Registered with US (FDA) AU (TGA)	Rxsight, Inc.	2026-06-08	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System MEDTRONIC SOFAMOR DANEK USA, INC. Cleared 2026-06-05 Registered with US (FDA)	MEDTRONIC SOFAMOR DANEK USA, INC.	2026-06-05	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)
AbsorbaSeal 5.6.7F Vascular Closure Device Cyndrx, LLC Cleared 2026-06-05 Registered with US (FDA)	Cyndrx, LLC	2026-06-05	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)
FieldFlex Steerable Sheath Centerpoint Systems Cleared 2026-06-05 Registered with US (FDA)	Centerpoint Systems	2026-06-05	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)
Occlutech Pistol Pusher Occlutech Holding AG Cleared 2026-06-05 Registered with US (FDA)	Occlutech Holding AG	2026-06-05	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)
Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG) Unimed Medical Supplies, Inc. Cleared 2026-06-05 Registered with US (FDA)	Unimed Medical Supplies, Inc.	2026-06-05	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)
PRECISE PRO RX Nitinol Stent System Cordis US Corp Cleared 2026-06-05 Registered with US (FDA)	Cordis US Corp	2026-06-05	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)
Digital C-ARM with 3D Allengers Medical Systems Limited Cleared 2026-06-05 Registered with US (FDA)	Allengers Medical Systems Limited	2026-06-05	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)
FARAPULSE™ Pulsed Field Ablation System Farapulse, Inc. Cleared 2026-06-05 Registered with US (FDA) UK (MHRA) AU (TGA)	Farapulse, Inc.	2026-06-05	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
FlexAbility™ Ablation Catheter; FlexAbilityTM Ablation Catheter, Sensor EnabledTM Abbott Medical Cleared 2026-06-05 Registered with US (FDA)	Abbott Medical	2026-06-05	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)
iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating Nextstep Arthopedix, LLC Cleared 2026-06-05 Registered with US (FDA)	Nextstep Arthopedix, LLC	2026-06-05	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)
TactiFlex™ Ablation Catheter, Sensor Enabled™ Abbott Medical Cleared 2026-06-05 Registered with US (FDA) Canada (Health Canada)	Abbott Medical	2026-06-05	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts Edwards Lifesciences, LLC Cleared 2026-06-05 Registered with US (FDA)	Edwards Lifesciences, LLC	2026-06-05	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)
EyeBOX SNAP Oculogica, Inc. Cleared 2026-06-05 Registered with US (FDA) Canada (Health Canada)	Oculogica, Inc.	2026-06-05	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
VEOFIX Snap Off Screw Steps Ortho Cleared 2026-06-05 Registered with US (FDA)	Steps Ortho	2026-06-05	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)
Catalyze BioTissue Holdings, Inc. Cleared 2026-06-05 Registered with US (FDA)	BioTissue Holdings, Inc.	2026-06-05	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)
Prospera Spinal Cord Stimulation (SCS) System; Resilience Percutaneous Lead; Embrace One; TrueLock Biotronik Nro, Inc. Cleared 2026-06-05 Registered with US (FDA)	Biotronik Nro, Inc.	2026-06-05	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)
CPR Uni-padz Electrode Zoll Medical Corp Cleared 2026-06-05 Registered with US (FDA) UK (MHRA)	Zoll Medical Corp	2026-06-05	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ St. Jude Medical, Inc. Cleared 2026-06-05 Registered with US (FDA)	St. Jude Medical, Inc.	2026-06-05	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)
Alma TED+ System Alma Lasers , Ltd. Cleared 2026-06-05 Registered with US (FDA)	Alma Lasers , Ltd.	2026-06-05	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)
Power Wheelchair (N5515A, N5516, N5517A, N5519) Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Cleared 2026-06-05 Registered with US (FDA)	Zhejiang Innuovo Rehabilitation Devices Co.,Ltd	2026-06-05	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)
APTUS Clavicle System 2.8 Medartis, Inc. Cleared 2026-06-05 Registered with US (FDA)	Medartis, Inc.	2026-06-05	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)
Vial Adapter HANGZHOU QIANTANG LONGYUE BIOTECHNOLOGY CO., LTD. Cleared 2026-06-05 Registered with US (FDA) Canada (Health Canada) AU (TGA) EU (EUDAMED)	HANGZHOU QIANTANG LONGYUE BIOTECHNOLOGY CO., LTD.	2026-06-05	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
PRO-Kinetic Energy Coronary Stent System Biotronik, GmbH & Co. Cleared 2026-06-05 Registered with US (FDA) UK (MHRA)	Biotronik, GmbH & Co.	2026-06-05	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test Assure Tech. Co., Ltd. Cleared 2026-06-05 Registered with US (FDA)	Assure Tech. Co., Ltd.	2026-06-05	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)
Perfect-O Ostial Positioning Catheter Balosmark, Inc. Cleared 2026-06-05 Registered with US (FDA)	Balosmark, Inc.	2026-06-05	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)
OrganOx metra System Organox Limited Cleared 2026-06-05 Registered with US (FDA)	Organox Limited	2026-06-05	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)
Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent System Stent S Medtronic Vascular Cleared 2026-06-05 Registered with US (FDA)	Medtronic Vascular	2026-06-05	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)
Precision S 4K Sinuscope Stryker Endoscopy Cleared 2026-06-04 Registered with US (FDA)	Stryker Endoscopy	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)
CollaCote™, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery 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)
HYDRUS MICROSTENT Alcon Research, Ltd. Cleared 2026-06-04 Registered with US (FDA)	Alcon Research, 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)
Instrument Exit Point on Touch Surgery™ Aide Covidien Cleared 2026-06-04 Registered with US (FDA)	Covidien	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)