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.

3,686 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
MAGNETOM Free.Max; MAGNETOM Free.Star Siemens Shenzhen Magnetic Resonance , Ltd. Cleared 2026-09-01 Registered with US (FDA)	Siemens Shenzhen Magnetic Resonance , Ltd.	2026-09-01	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)
UNIDRIVE Select System Karl Storz SE & CO.KG Cleared 2026-09-01 Registered with US (FDA)	Karl Storz SE & CO.KG	2026-09-01	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)
Wearable breast pump (Model: XN/MD-2249BS, ZFHF) Guangdong Horigen Mother & Baby Products Co., Ltd. Cleared 2026-09-01 Registered with US (FDA)	Guangdong Horigen Mother & Baby Products Co., Ltd.	2026-09-01	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)
RadiForce MX247W EIZO Corporation Cleared 2026-09-01 Registered with US (FDA)	EIZO Corporation	2026-09-01	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)
Arthrex DynaNite Staples Arthrex, Inc. Cleared 2026-09-01 Registered with US (FDA)	Arthrex, Inc.	2026-09-01	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)
SK Knee System Just Medical Devices (Tianjin) Co., Ltd. Cleared 2026-09-01 Registered with US (FDA)	Just Medical Devices (Tianjin) Co., Ltd.	2026-09-01	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)
CO2 Laser System (MBT- CO2 Laser) Beijing Mega Beauty Technology Co., Ltd. Cleared 2026-09-01 Registered with US (FDA)	Beijing Mega Beauty Technology Co., Ltd.	2026-09-01	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)
AMI™ Plasma Cartridge, AMI™ Sequitur Health Corp. Cleared 2026-09-01 Registered with US (FDA)	Sequitur Health Corp.	2026-09-01	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)
PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3) PRIMED MEDICAL PRODUCTS INC. Cleared 2026-09-01 Registered with US (FDA)	PRIMED MEDICAL PRODUCTS INC.	2026-09-01	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)
Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M GE HealthCare Finland OY Cleared 2026-09-01 Registered with US (FDA)	GE HealthCare Finland OY	2026-09-01	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)
SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003) Hironic Co., Ltd. Cleared 2026-08-31 Registered with US (FDA)	Hironic Co., Ltd.	2026-08-31	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)
Nova HD+ Aura Wellness, LLC Cleared 2026-08-31 Registered with US (FDA)	Aura Wellness, LLC	2026-08-31	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)
EZFluence (RADEZ V2) Radformation Cleared 2026-08-31 Registered with US (FDA)	Radformation	2026-08-31	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)
MULTIX Impact, MULTIX Impact C Siemens Medical Solutions USA, Inc. Cleared 2026-08-31 Registered with US (FDA)	Siemens Medical Solutions USA, Inc.	2026-08-31	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)
Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) Guilin Kevin Peter Technology Co Ltd Cleared 2026-08-31 Registered with US (FDA)	Guilin Kevin Peter Technology Co Ltd	2026-08-31	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)
Automatic Digital Blood Pressure monitor (LD-526) Honsun(Nantong) Co., Ltd. Cleared 2026-08-31 Registered with US (FDA)	Honsun(Nantong) Co., Ltd.	2026-08-31	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)
Aerloom Evolym, LLC Cleared 2026-08-31 Registered with US (FDA)	Evolym, LLC	2026-08-31	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)
ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 Abbott Diagnostics Scarborough, Inc Cleared 2026-08-31 Registered with US (FDA)	Abbott Diagnostics Scarborough, Inc	2026-08-31	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)
Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter Global Life Sciences Solutions USA, LLC Cleared 2026-08-31 Registered with US (FDA)	Global Life Sciences Solutions USA, LLC	2026-08-31	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)
Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907) Kam Yuen Plastic Products , Ltd. Cleared 2026-08-31 Registered with US (FDA)	Kam Yuen Plastic Products , Ltd.	2026-08-31	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)
AGENT Paclitaxel-Coated Balloon Catheter Boston Scientific Corp Cleared 2026-08-28 Registered with US (FDA)	Boston Scientific Corp	2026-08-28	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)
Carescape Canvas 1000; Carescape Canvas Smart Display GE HealthCare Finland OY Cleared 2026-08-28 Registered with US (FDA)	GE HealthCare Finland OY	2026-08-28	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)
Tigertriever 13 Ultra Revascularization Device Rapid-Medical , Ltd. Cleared 2026-08-28 Registered with US (FDA)	Rapid-Medical , Ltd.	2026-08-28	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)
WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System Boston Scientific Corp Cleared 2026-08-28 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Boston Scientific Corp	2026-08-28	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Fule Vertebroplasty Balloon Catheter Beijing Fule Science & Technology Development Co., Ltd. Cleared 2026-08-28 Registered with US (FDA)	Beijing Fule Science & Technology Development Co., Ltd.	2026-08-28	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)
Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK) CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD. Cleared 2026-08-28 Registered with US (FDA)	CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.	2026-08-28	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)
STAARVISC II SODIUM HYALURONATE AND SHELLGEL SODIUM HYALURONATE Anika Therapeutics, Inc Cleared 2026-08-28 Registered with US (FDA)	Anika Therapeutics, Inc	2026-08-28	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)
FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog) Ortler Global Tibbi Gerecler Anonim Sirketi Cleared 2026-08-28 Registered with US (FDA)	Ortler Global Tibbi Gerecler Anonim Sirketi	2026-08-28	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)
Automatic Core Biopsy Instrument Zhejiang CuraWay Medical Technology Co, Ltd Cleared 2026-08-28 Registered with US (FDA) AU (TGA) EU (EUDAMED)	Zhejiang CuraWay Medical Technology Co, Ltd	2026-08-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
Rayvolve AZchest Azmed Sas Cleared 2026-08-28 Registered with US (FDA)	Azmed Sas	2026-08-28	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)
Juvéderm Ultra, Juvéderm Ultra XC, Juvéderm Ultra Plus XC ALLERGAN Cleared 2026-08-28 Registered with US (FDA)	ALLERGAN	2026-08-28	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)
Kiba CTO Crossing Catheter Reflow Medical Cleared 2026-08-28 Registered with US (FDA)	Reflow Medical	2026-08-28	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)
Model 2740 Programmer Cable Printed Circuit Board Assembly Inspire Medical Systems Cleared 2026-08-28 Registered with US (FDA)	Inspire Medical Systems	2026-08-28	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)
Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02) Zhengzhou PZ Laser Slim Technology Co Limited Cleared 2026-08-28 Registered with US (FDA)	Zhengzhou PZ Laser Slim Technology Co Limited	2026-08-28	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 Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190) Roche Molecular Systems, Inc. Cleared 2026-08-28 Registered with US (FDA)	Roche Molecular Systems, Inc.	2026-08-28	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® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190) Roche Molecular Systems, Inc. Cleared 2026-08-28 Registered with US (FDA)	Roche Molecular Systems, Inc.	2026-08-28	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)
Orthovisc, Sodium Hyaluronic Anika Therapeutics, Inc Cleared 2026-08-28 Registered with US (FDA)	Anika Therapeutics, Inc	2026-08-28	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)
X-Guide Surgical Navigation System X-Nav Technologies, LLC Cleared 2026-08-28 Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA)	X-Nav Technologies, LLC	2026-08-28	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Surpass Evolve; Surpass Elite FDS STRYKER NEUROVASCULAR Cleared 2026-08-28 Registered with US (FDA) AU (TGA)	STRYKER NEUROVASCULAR	2026-08-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Mpact 3D Metal Foam Medacta International S.A. Cleared 2026-08-28 Registered with US (FDA)	Medacta International S.A.	2026-08-28	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)
XIENCE Alpine; XIENCE Sierra; XIENCE PROs; XIENCE Skypoint Everolimus Eluting Coronary Stent Systems Abbott Vascular, Inc. Cleared 2026-08-28 Registered with US (FDA)	Abbott Vascular, Inc.	2026-08-28	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)
LINQ II Insertable Cardiac Monitor (ICM) (LNQ22) Medtronic, Inc Cleared 2026-08-28 Registered with US (FDA)	Medtronic, Inc	2026-08-28	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)
RHA® Kiss Volume Teoxane S.A. Cleared 2026-08-28 Registered with US (FDA)	Teoxane S.A.	2026-08-28	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)
AmplatzerTM Amulet Left Atrial Appendage Occluder Abbott Medical Cleared 2026-08-28 Registered with US (FDA) AU (TGA)	Abbott Medical	2026-08-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Zoom 4S Catheter Imperative Care, Inc. Cleared 2026-08-28 Registered with US (FDA)	Imperative Care, Inc.	2026-08-28	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)
SKINVIVE by JUVEDERM® ALLERGAN Cleared 2026-08-28 Registered with US (FDA) Canada (Health Canada) AU (TGA)	ALLERGAN	2026-08-28	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
LIFEPAK 15 MONITOR/DEFIBRILLATOR Physio-Control, Inc. Cleared 2026-08-28 Registered with US (FDA) Canada (Health Canada)	Physio-Control, Inc.	2026-08-28	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Primal K-Wire (P99-193-1410) Paragon 28, Inc Cleared 2026-08-28 Registered with US (FDA)	Paragon 28, Inc	2026-08-28	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)
Acticor Sky DR-T (481987); Rivacor Sky DR-T (481982); Rivacor Rise DR-T (482018); Rivacor Aura DR-T (482014) Biotronik, GmbH & Co. Cleared 2026-08-27 Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA)	Biotronik, GmbH & Co.	2026-08-27	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
ETHIZIA Hemostatic Patch ETHICON LLC Cleared 2026-08-27 Registered with US (FDA)	ETHICON LLC	2026-08-27	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)