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.

3,689 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
CEPHX3D Orca Dental AI , Ltd. Cleared 2026-03-05 Registered with US (FDA)	Orca Dental AI , Ltd.	2026-03-05	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)
QT Scanner 2000 Model A Qt Imaging, Inc. Cleared 2026-03-04 Registered with US (FDA)	Qt Imaging, Inc.	2026-03-04	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)
SureSmile Software Dentsply Sirona Cleared 2026-03-04 Registered with US (FDA)	Dentsply Sirona	2026-03-04	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)
Oncomine Dx Target Test Life Technologies Holdings Pte Ltd Cleared 2026-03-04 Registered with US (FDA) UK (MHRA)	Life Technologies Holdings Pte Ltd	2026-03-04	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Klär Lite (RCW-KL1000) Radcliffe Watts, LLC Cleared 2026-03-04 Registered with US (FDA)	Radcliffe Watts, LLC	2026-03-04	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)
STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER Staar Surgical Co. Cleared 2026-03-04 Registered with US (FDA)	Staar Surgical Co.	2026-03-04	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)
ANTERIS Thoracolumbar Plate System Spinecraft, Inc. Cleared 2026-03-04 Registered with US (FDA)	Spinecraft, Inc.	2026-03-04	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)
LifeVac Lifevac, LLC Cleared 2026-03-04 Registered with US (FDA)	Lifevac, LLC	2026-03-04	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)
Aevumed FENIX Suture Anchor Aevumed, Inc. Cleared 2026-03-04 Registered with US (FDA)	Aevumed, Inc.	2026-03-04	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)
Mendit Escala Medical Cleared 2026-03-04 Registered with US (FDA)	Escala Medical	2026-03-04	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)
TENS/EMS device (GUSE01) Globalcare Medical Technology Co, Ltd Cleared 2026-03-04 Registered with US (FDA)	Globalcare Medical Technology Co, Ltd	2026-03-04	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)
Electric Wheelchair (MP148) Suzhou Master Machinery Manufacturing Co.,Ltd Cleared 2026-03-04 Registered with US (FDA)	Suzhou Master Machinery Manufacturing Co.,Ltd	2026-03-04	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)
KS Healing Abutment Osstem Implant Co Ltd Cleared 2026-03-04 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	Osstem Implant Co Ltd	2026-03-04	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery Char Devicor Medical Products, Inc. Cleared 2026-03-04 Registered with US (FDA)	Devicor Medical Products, Inc.	2026-03-04	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)
Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class Element Science, Inc. Cleared 2026-03-04 Registered with US (FDA)	Element Science, Inc.	2026-03-04	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)
LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD. Cleared 2026-03-04 Registered with US (FDA)	SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD.	2026-03-04	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)
Dentis SQ-SL AXEL Fixture Dentis Co., Ltd. Cleared 2026-03-04 Registered with US (FDA)	Dentis Co., Ltd.	2026-03-04	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)
Active Intramedullary (AIM) Tibial Nail System Satori Orthopaedics, Inc. Cleared 2026-03-04 Registered with US (FDA)	Satori Orthopaedics, Inc.	2026-03-04	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)
LED Therapy Light (COB1400, HP1800PRO) Shenzhen Hanhua Opto Co., Ltd. Cleared 2026-03-03 Registered with US (FDA)	Shenzhen Hanhua Opto Co., Ltd.	2026-03-03	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)
Surgical Face Mask (Ear mount) Zhejiang Hangkang Medical Equipment Co., Ltd. Cleared 2026-03-03 Registered with US (FDA)	Zhejiang Hangkang Medical Equipment Co., Ltd.	2026-03-03	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)
Mosaic Porcine Bioprosthesis Medtronic, Inc Cleared 2026-03-03 Registered with US (FDA) UK (MHRA) AU (TGA)	Medtronic, Inc	2026-03-03	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Annalise Enterprise Harrison-AI Medical Pty Ltd Cleared 2026-03-03 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Harrison-AI Medical Pty Ltd	2026-03-03	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
SOTA Cloud Smart Sensor (1.5) Sota Cloud Corp. Cleared 2026-03-03 Registered with US (FDA)	Sota Cloud Corp.	2026-03-03	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)
PathLoc Lumbar Plate System L&K BIOMED CO., LTD Cleared 2026-03-03 Registered with US (FDA)	L&K BIOMED CO., LTD	2026-03-03	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 Treatment Machine (CFR3M1) Haidari Beauty Technology (Beijing) Co., , Ltd. Cleared 2026-03-03 Registered with US (FDA)	Haidari Beauty Technology (Beijing) Co., , Ltd.	2026-03-03	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)
ZAFIRA® NEW STETIC S.A. Cleared 2026-03-03 Registered with US (FDA)	NEW STETIC S.A.	2026-03-03	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 (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) Ram.Shaw Pte. , Ltd. Cleared 2026-03-03 Registered with US (FDA)	Ram.Shaw Pte. , Ltd.	2026-03-03	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)
Bond-PR™ Universal Adhesive Premier Dental Products Co. Cleared 2026-03-03 Registered with US (FDA)	Premier Dental Products Co.	2026-03-03	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 Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button Arthrex, Inc. Cleared 2026-03-03 Registered with US (FDA)	Arthrex, Inc.	2026-03-03	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 Nano FiberTak Suture Anchor Arthrex, Inc. Cleared 2026-03-02 Registered with US (FDA)	Arthrex, Inc.	2026-03-02	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)
MESI mTABLET SPIRO Mesi D.O.O. Cleared 2026-03-02 Registered with US (FDA)	Mesi D.O.O.	2026-03-02	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)
VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System SYNTHES GMBH Cleared 2026-03-02 Registered with US (FDA)	SYNTHES GMBH	2026-03-02	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)
KARL STORZ Mediastinoscopes and Instruments Karl Storz SE & CO.KG Cleared 2026-03-02 Registered with US (FDA)	Karl Storz SE & CO.KG	2026-03-02	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)
POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) Gyrus Acmi, Inc. Cleared 2026-03-02 Registered with US (FDA)	Gyrus Acmi, Inc.	2026-03-02	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)
Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) Myofunctional Research Corp. Pty. , Ltd. Cleared 2026-03-02 Registered with US (FDA)	Myofunctional Research Corp. Pty. , Ltd.	2026-03-02	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)
UltraPrint-Dental Hard Splint UV GUANGZHOU HEYGEARS IMC.INC Cleared 2026-03-02 Registered with US (FDA)	GUANGZHOU HEYGEARS IMC.INC	2026-03-02	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)
Clarius Ejection Fraction AI Clarius Mobile Health Corp. Cleared 2026-03-02 Registered with US (FDA)	Clarius Mobile Health Corp.	2026-03-02	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)
Microwave Ablation Device Nanjing Dewen Medical Technology Co., Ltd. Cleared 2026-03-02 Registered with US (FDA)	Nanjing Dewen Medical Technology Co., Ltd.	2026-03-02	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 Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13) Nanjing Devin Medical Technology Co., Ltd. Cleared 2026-03-02 Registered with US (FDA)	Nanjing Devin Medical Technology Co., Ltd.	2026-03-02	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)
"FLNT Base" and "FLNT Temp" Liaoning Upcera Co., Ltd. Cleared 2026-03-02 Registered with US (FDA)	Liaoning Upcera Co., Ltd.	2026-03-02	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)
DURASEAL EXACT SPINE SEALANT SYSTEM Integra Lifesciences Corp. Cleared 2026-02-27 Registered with US (FDA)	Integra Lifesciences Corp.	2026-02-27	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)
DURASEAL DURAL SEALANT SYSTEM Integra Lifesciences Corp. Cleared 2026-02-27 Registered with US (FDA) UK (MHRA) AU (TGA)	Integra Lifesciences Corp.	2026-02-27	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Allday Moisturizing Rinse Elevate Oral Care Cleared 2026-02-27 Registered with US (FDA)	Elevate Oral Care	2026-02-27	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)
AViTA Pulse Oximeter (SP61) Avita Corporation Cleared 2026-02-27 Registered with US (FDA)	Avita Corporation	2026-02-27	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)
Ligence Heart Ligence Uab Cleared 2026-02-27 Registered with US (FDA)	Ligence Uab	2026-02-27	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)
Evala Nerve Stimulator (EPNR002) Epineuron Technologies, Inc. Cleared 2026-02-27 Registered with US (FDA)	Epineuron Technologies, Inc.	2026-02-27	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)
HKT Anatomical Locking Trauma System Hankil Tech Medical Co., Ltd. Cleared 2026-02-27 Registered with US (FDA)	Hankil Tech Medical Co., Ltd.	2026-02-27	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)
Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) Beijing HuaCheng Taike Technology Co., Ltd. Cleared 2026-02-27 Registered with US (FDA)	Beijing HuaCheng Taike Technology Co., Ltd.	2026-02-27	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)
Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) Beijing HuaCheng Taike Technology Co., Ltd. Cleared 2026-02-27 Registered with US (FDA)	Beijing HuaCheng Taike Technology Co., Ltd.	2026-02-27	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)
LigaMend Riverpoint Medical Cleared 2026-02-27 Registered with US (FDA)	Riverpoint Medical	2026-02-27	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)