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
CARTO™ 3 EP Navigation System V8.4 Biosense Webster, Inc. Cleared 2026-02-20 Registered with US (FDA)	Biosense Webster, Inc.	2026-02-20	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)
SPRY TMS Therapy System (0550) Soterix Medical, Inc. Cleared 2026-02-20 Registered with US (FDA)	Soterix Medical, Inc.	2026-02-20	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)
SynCardia Total Artificial Heart (STAH) System Syncardia Systems, LLC Cleared 2026-02-20 Registered with US (FDA)	Syncardia Systems, LLC	2026-02-20	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)
KLS Martin Ixos System KLS Martin SE & Co KG Cleared 2026-02-20 Registered with US (FDA)	KLS Martin SE & Co KG	2026-02-20	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)
CARA System Cara Medical, Ltd. Cleared 2026-02-20 Registered with US (FDA)	Cara Medical, Ltd.	2026-02-20	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)
BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) Bd Cleared 2026-02-20 Registered with US (FDA)	Bd	2026-02-20	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)
Allurion Gastric Balloon System ALLURION TECHNOLOGIES, INC. Cleared 2026-02-20 Registered with US (FDA) EU (EUDAMED)	ALLURION TECHNOLOGIES, INC.	2026-02-20	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) CASEBIOSCIENCE INC. Cleared 2026-02-20 Registered with US (FDA)	CASEBIOSCIENCE INC.	2026-02-20	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)
AeroPace® System Lungpacer Medical USA, Inc. Cleared 2026-02-20 Registered with US (FDA)	Lungpacer Medical USA, Inc.	2026-02-20	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)
LF Process Indicator Tape for Steam Sterilization Intertape Polymer, Inc. Cleared 2026-02-20 Registered with US (FDA)	Intertape Polymer, Inc.	2026-02-20	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 Heel Lancet Ningbo Medsun Medical Co., Ltd. Cleared 2026-02-20 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Ningbo Medsun Medical Co., Ltd.	2026-02-20	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
TrueFit Bolus Adaptiiv Medical Technologies, Inc. Cleared 2026-02-19 Registered with US (FDA)	Adaptiiv Medical Technologies, Inc.	2026-02-19	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)
VERTICALE GPS Instruments Silony Medical GmbH Cleared 2026-02-19 Registered with US (FDA)	Silony Medical GmbH	2026-02-19	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)
Meniscus Versaflex GM Dos Reis Industria e Comercio Ltda. Cleared 2026-02-19 Registered with US (FDA)	GM Dos Reis Industria e Comercio Ltda.	2026-02-19	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)
LacertaMatrix Lacerta Life Sciences Cleared 2026-02-19 Registered with US (FDA)	Lacerta Life Sciences	2026-02-19	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)
Retrograde Coronary Sinus Perfusion Cannulae Medtronic, Inc Cleared 2026-02-19 Registered with US (FDA)	Medtronic, Inc	2026-02-19	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)
Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) Efofex, Inc. Cleared 2026-02-19 Registered with US (FDA)	Efofex, Inc.	2026-02-19	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)
Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe Cmt Health Pte., Ltd. Cleared 2026-02-19 Registered with US (FDA)	Cmt Health Pte., Ltd.	2026-02-19	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)
BioMimics 3D Vascular Stent System Veryan Medical Limited Cleared 2026-02-19 Registered with US (FDA) UK (MHRA)	Veryan Medical Limited	2026-02-19	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Access anti-HBc Total Beckman Coulter, Inc. Cleared 2026-02-19 Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA)	Beckman Coulter, Inc.	2026-02-19	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Total Temporomandibular Joint Replacement System Biomet Microfixation Cleared 2026-02-19 Registered with US (FDA)	Biomet Microfixation	2026-02-19	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)
ATLAS™ Expandable Osteotomy Wedge System Mirus, LLC Cleared 2026-02-19 Registered with US (FDA)	Mirus, LLC	2026-02-19	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)
Portable Dental X-ray Device (GT-1) Guilin Refine Medical Instrument Co., Ltd. Cleared 2026-02-19 Registered with US (FDA)	Guilin Refine Medical Instrument Co., Ltd.	2026-02-19	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)
Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor Stryker Leibinger Cleared 2026-02-19 Registered with US (FDA)	Stryker Leibinger	2026-02-19	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)
Acclarent Aera Eustachian Tube Balloon Dilation System ACCLARENT INC. Cleared 2026-02-19 Registered with US (FDA)	ACCLARENT INC.	2026-02-19	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)
SkinStylus SteriLock MicroSystem (MP1209SL) Esthetic Medical, Inc. Cleared 2026-02-19 Registered with US (FDA)	Esthetic Medical, Inc.	2026-02-19	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)
Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) Alphatec Spine, Inc. Cleared 2026-02-19 Registered with US (FDA)	Alphatec Spine, Inc.	2026-02-19	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)
Monaco RTP System (6.3) Elekta Solutions AB Cleared 2026-02-19 Registered with US (FDA)	Elekta Solutions AB	2026-02-19	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)
AuST CSP Introducer Centerpoint Systems Cleared 2026-02-19 Registered with US (FDA)	Centerpoint Systems	2026-02-19	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)
Erchonia DPN Laser (Model# EVRL) ERCHONIA CORPORATION Cleared 2026-02-19 Registered with US (FDA)	ERCHONIA CORPORATION	2026-02-19	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)
AS Software Version Asera As Software, Inc. Cleared 2026-02-19 Registered with US (FDA)	As Software, Inc.	2026-02-19	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)
UROVYSION BLADDER CANCER KIT Abbott Molecular, Inc. Cleared 2026-02-18 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Abbott Molecular, Inc.	2026-02-18	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Alere NT-proBNP for Alinity i Axis-Shield Diagnostics, Ltd. Cleared 2026-02-18 Registered with US (FDA)	Axis-Shield Diagnostics, Ltd.	2026-02-18	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)
Vysis ALK Break Apart FISH Probe Kit Abbott Molecular, Inc. Cleared 2026-02-18 Registered with US (FDA) UK (MHRA)	Abbott Molecular, Inc.	2026-02-18	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert Howmedica Osteonics Corp., Dba Stryker Orthopaedics Cleared 2026-02-18 Registered with US (FDA)	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2026-02-18	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)
Mobility Scooter (S3) Shenzhen Zhimahuaerkai Technology Co, Ltd Cleared 2026-02-18 Registered with US (FDA)	Shenzhen Zhimahuaerkai Technology Co, Ltd	2026-02-18	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)
1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality Stryker Endoscopy Cleared 2026-02-18 Registered with US (FDA)	Stryker Endoscopy	2026-02-18	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)
PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) Methyl Co., Ltd. Cleared 2026-02-18 Registered with US (FDA)	Methyl Co., Ltd.	2026-02-18	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)
Nobel Biocare S Series Implants Nobel Biocare AB Cleared 2026-02-18 Registered with US (FDA)	Nobel Biocare AB	2026-02-18	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)
SetPoint System SetPoint Medical Cleared 2026-02-18 Registered with US (FDA)	SetPoint Medical	2026-02-18	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)
BTL-754FF Btl Industries, Ltd. Cleared 2026-02-18 Registered with US (FDA)	Btl Industries, Ltd.	2026-02-18	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)
VYSIS CLL FISH PROBE KIT Abbott Molecular, Inc. Cleared 2026-02-18 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Abbott Molecular, Inc.	2026-02-18	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Adaptos®Fuse Bone Graft Biomendex OY Cleared 2026-02-17 Registered with US (FDA)	Biomendex OY	2026-02-17	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)
Electric Wheelchair (W-A807, W-A807L) Ningbo Shenyu Medical Equipment Co, Ltd Cleared 2026-02-17 Registered with US (FDA)	Ningbo Shenyu Medical Equipment Co, Ltd	2026-02-17	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)
Versus™ Catheter (VS110-9NB) Liquet Medical, Inc. Cleared 2026-02-17 Registered with US (FDA)	Liquet Medical, Inc.	2026-02-17	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)
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear CooperVision, Inc. Cleared 2026-02-17 Registered with US (FDA)	CooperVision, Inc.	2026-02-17	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)
FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit FUJIFILM Corporation Cleared 2026-02-17 Registered with US (FDA)	FUJIFILM Corporation	2026-02-17	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)
IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) Centerline Biomedical, Inc. Cleared 2026-02-17 Registered with US (FDA)	Centerline Biomedical, Inc.	2026-02-17	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)
Biosteon® Screw Biocomposites Ltd Cleared 2026-02-17 Registered with US (FDA) UK (MHRA)	Biocomposites Ltd	2026-02-17	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. Cleared 2026-02-17 Registered with US (FDA)	Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.	2026-02-17	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)