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.

3,663 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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) Zhengzhou PZ Laser Slim Technology Co Limited Cleared 2026-08-27 Registered with US (FDA)	Zhengzhou PZ Laser Slim Technology Co Limited	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)
Iconix Knotless T Riverpoint Medical Cleared 2026-08-27 Registered with US (FDA)	Riverpoint Medical	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)
Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) GEBAUER COMPANY Cleared 2026-08-27 Registered with US (FDA)	GEBAUER COMPANY	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)
GC85A Samsung Electronics Co., Ltd. Cleared 2026-08-27 Registered with US (FDA) Canada (Health Canada) EU (EUDAMED)	Samsung Electronics Co., Ltd.	2026-08-27	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
EasyCare Tx 2 ResMed PTY Ltd Cleared 2026-08-27 Registered with US (FDA) Canada (Health Canada)	ResMed PTY Ltd	2026-08-27	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F) Olympus Medical Systems Corporation Cleared 2026-08-27 Registered with US (FDA)	Olympus Medical Systems Corporation	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)
Glidewell™ Denture Base Resin Prismatik Dentalcraft, Inc. Cleared 2026-08-27 Registered with US (FDA)	Prismatik Dentalcraft, Inc.	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)
Scarlet Pro (Scarlet Pro) VIOL Medical Co., Ltd. Cleared 2026-08-27 Registered with US (FDA)	VIOL Medical Co., Ltd.	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)
35 Helix Guidewire Piraeus Medical Cleared 2026-08-27 Registered with US (FDA)	Piraeus Medical	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)
GenesisX RMN Stereotaxis, Inc. Cleared 2026-08-27 Registered with US (FDA) UK (MHRA)	Stereotaxis, Inc.	2026-08-27	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Gastrointestinal Videoscope Olympus GIF-2T1500 Olympus Medical Systems Corporation Cleared 2026-08-27 Registered with US (FDA)	Olympus Medical Systems Corporation	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)
CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System Ascensia Diabetes Care Cleared 2026-08-27 Registered with US (FDA)	Ascensia Diabetes Care	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)
Disposable Distal Attachment D-201-13404 Olympus Medical Systems Corporation Cleared 2026-08-27 Registered with US (FDA)	Olympus Medical Systems Corporation	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)
Optiflow Oxygen Kit (AA484J) Fisher &Paykel Healthcare , Ltd. Cleared 2026-08-27 Registered with US (FDA)	Fisher &Paykel Healthcare , Ltd.	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)
Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT) Ram.Shaw Pte. , Ltd. Cleared 2026-08-27 Registered with US (FDA)	Ram.Shaw Pte. , Ltd.	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)
Dexus Prosthetic System (MSL2, MSR2) Zhejiang Qiangnao Technology Co.,Ltd Cleared 2026-08-27 Registered with US (FDA)	Zhejiang Qiangnao Technology Co.,Ltd	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)
Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP) Berkeley Advanced Biomaterials, Inc. Cleared 2026-08-27 Registered with US (FDA)	Berkeley Advanced Biomaterials, Inc.	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)
MRIA Radiation Therapy Information System (MRIA) Manteia Technologies Co., Ltd. Cleared 2026-08-26 Registered with US (FDA)	Manteia Technologies Co., Ltd.	2026-08-26	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)
Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns Principle & Will Co., Ltd. Cleared 2026-08-26 Registered with US (FDA)	Principle & Will Co., Ltd.	2026-08-26	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)
Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279) Maquet Critical Care AB Cleared 2026-08-26 Registered with US (FDA)	Maquet Critical Care AB	2026-08-26	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)
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus) Joytech Healthcare Co. , Ltd. Cleared 2026-08-26 Registered with US (FDA)	Joytech Healthcare Co. , Ltd.	2026-08-26	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)
OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor Sony Corporation Cleared 2026-08-26 Registered with US (FDA)	Sony Corporation	2026-08-26	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)
LithoVue Elite Digital Flexible Ureteroscope System Boston Scientific Corp Cleared 2026-08-26 Registered with US (FDA)	Boston Scientific Corp	2026-08-26	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)
VariLift-C Cervical Interbody Fusion System Wenzel Spine Cleared 2026-08-26 Registered with US (FDA)	Wenzel Spine	2026-08-26	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)
Ponto 5 Mini; Ponto 5 Superpower Oticon Medical AB Cleared 2026-08-26 Registered with US (FDA)	Oticon Medical AB	2026-08-26	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)
GraftGun Universal Graft Delivery System (GDS) SurGenTec, LLC Cleared 2026-08-26 Registered with US (FDA)	SurGenTec, LLC	2026-08-26	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)
StimTrial Neuromodulation System Bioventus, LLC Cleared 2026-08-26 Registered with US (FDA)	Bioventus, LLC	2026-08-26	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)
HOPKINS Telescopes for Arthroscopy Karl Storz SE & CO.KG Cleared 2026-08-26 Registered with US (FDA)	Karl Storz SE & CO.KG	2026-08-26	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)
Heartvue.Proton Heartvue.ai, Inc. Cleared 2026-08-26 Registered with US (FDA)	Heartvue.ai, Inc.	2026-08-26	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 blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) Sterilance Medical(Suzhou), Inc. Cleared 2026-08-25 Registered with US (FDA)	Sterilance Medical(Suzhou), Inc.	2026-08-25	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)
MONOFIX PDO Samyang Biopharm Corporation Cleared 2026-08-25 Registered with US (FDA) EU (EUDAMED)	Samyang Biopharm Corporation	2026-08-25	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System Abbott Diabetes Care, Inc. Cleared 2026-08-25 Registered with US (FDA)	Abbott Diabetes Care, Inc.	2026-08-25	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)
Report Studio Beacon Biosignals, Inc. Cleared 2026-08-25 Registered with US (FDA)	Beacon Biosignals, Inc.	2026-08-25	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)
Ceevra Reveal 4 Ceevra, Inc. Cleared 2026-08-25 Registered with US (FDA)	Ceevra, Inc.	2026-08-25	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)