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
UV Smart D60 UV Smart Technologies BV Cleared 2026-01-29 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	UV Smart Technologies BV	2026-01-29	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Falco Fusion System Mcnicoll Surgical, Inc. Cleared 2026-01-29 Registered with US (FDA)	Mcnicoll Surgical, Inc.	2026-01-29	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 Scooter (Mojo-T330) Dongguan Smarfody Mobility Technology CO, LTD Cleared 2026-01-29 Registered with US (FDA)	Dongguan Smarfody Mobility Technology CO, LTD	2026-01-29	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)
NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) Fresenius Medical Care Renal Therapies Group, LLC Cleared 2026-01-29 Registered with US (FDA)	Fresenius Medical Care Renal Therapies Group, LLC	2026-01-29	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)
Sacroiliac Joint Truss System (SJTS) 4Web Medical, Inc. Cleared 2026-01-28 Registered with US (FDA)	4Web Medical, Inc.	2026-01-28	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)
Hand Massager (SM004D) Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. Cleared 2026-01-28 Registered with US (FDA)	Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.	2026-01-28	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)
FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing Koru Medical Systems Cleared 2026-01-28 Registered with US (FDA)	Koru Medical Systems	2026-01-28	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)
MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) Impedimed Pty , Ltd. Cleared 2026-01-28 Registered with US (FDA)	Impedimed Pty , Ltd.	2026-01-28	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)
Aevumed PROTEKT Suture Anchor Aevumed, Inc. Cleared 2026-01-28 Registered with US (FDA)	Aevumed, Inc.	2026-01-28	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)
XeliteMed SuperM-Fix Spinal Bone Cement Xelite Biomed , Ltd. Cleared 2026-01-28 Registered with US (FDA)	Xelite Biomed , Ltd.	2026-01-28	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)
Sterilization Pouch/Roll Sterivic Medical Co., Ltd. Cleared 2026-01-28 Registered with US (FDA)	Sterivic Medical Co., Ltd.	2026-01-28	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)
Vena MicroAngioscope™ System Vena Medical Holdings Corp Cleared 2026-01-28 Registered with US (FDA)	Vena Medical Holdings Corp	2026-01-28	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)
Sleepiz One+ (Model 2.5) Sleepiz AG Cleared 2026-01-28 Registered with US (FDA)	Sleepiz AG	2026-01-28	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)
Womed Leaf Womed Sas Cleared 2026-01-28 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Womed Sas	2026-01-28	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
HERCEPTEST Agilent Technologies Singapore (International) Pte Ltd Cleared 2026-01-28 Registered with US (FDA) AU (TGA)	Agilent Technologies Singapore (International) Pte Ltd	2026-01-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
HIGHERDOSE Body Sculptor (Model: GS-03) SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD. Cleared 2026-01-28 Registered with US (FDA)	SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD.	2026-01-28	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)
Mpact 3D Metal Implants Extension – DMLS Technology Medacta International S.A. Cleared 2026-01-28 Registered with US (FDA)	Medacta International S.A.	2026-01-28	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)
NorthStar Mapping System Imricor Medical Systems, Inc. Cleared 2026-01-28 Registered with US (FDA) EU (EUDAMED)	Imricor Medical Systems, Inc.	2026-01-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Seg Pro V3 (RT-300) Ever Fortune.Ai, Co., Ltd. Cleared 2026-01-28 Registered with US (FDA)	Ever Fortune.Ai, Co., Ltd.	2026-01-28	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)
GBT Machine AIRFLOW Prophylaxis Master E.M.S Electro Medical Systems S.A Cleared 2026-01-28 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	E.M.S Electro Medical Systems S.A	2026-01-28	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
InbellaIgnite RF System Inbella Medical, Inc. Cleared 2026-01-27 Registered with US (FDA)	Inbella Medical, Inc.	2026-01-27	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)
Optima Coil System (OptiOne Coil System) Balt USA, LLC Cleared 2026-01-27 Registered with US (FDA)	Balt USA, LLC	2026-01-27	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)
Access anti-HAV IgM Beckman Coulter, Inc. Cleared 2026-01-27 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	Beckman Coulter, Inc.	2026-01-27	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Reusable 3 Button Fingerswitch Wand Soniquence LLC Cleared 2026-01-27 Registered with US (FDA)	Soniquence LLC	2026-01-27	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)
WOLVERINE™ Coronary Cutting Balloon™ Boston Scientific Corp Cleared 2026-01-27 Registered with US (FDA) UK (MHRA) AU (TGA)	Boston Scientific Corp	2026-01-27	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
MAC 7 Resting ECG Analysis System GE Medical Systems Information Technologies, Inc Cleared 2026-01-26 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	GE Medical Systems Information Technologies, Inc	2026-01-26	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Ascent3T Neonatal Magnetic Resonance Imaging System Eyas Medical Imaging, Inc. Cleared 2026-01-26 Registered with US (FDA)	Eyas Medical Imaging, Inc.	2026-01-26	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)
Tablo Hemodialysis System (PN-0008000, PN-0006000U) Outset Medical Cleared 2026-01-26 Registered with US (FDA)	Outset Medical	2026-01-26	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)
Vydence Family of Lasers Vydence Medical Industria E Commercio Ltda Cleared 2026-01-24 Registered with US (FDA)	Vydence Medical Industria E Commercio Ltda	2026-01-24	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)
Holmium Laser Therapeutic Apparatus (HZ-40) Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Cleared 2026-01-24 Registered with US (FDA)	Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.	2026-01-24	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)
TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD. Cleared 2026-01-23 Registered with US (FDA)	SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD.	2026-01-23	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)
Elitone for Men Elidah, Inc. Cleared 2026-01-23 Registered with US (FDA)	Elidah, Inc.	2026-01-23	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)
Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System Life Spine, LLC Cleared 2026-01-23 Registered with US (FDA)	Life Spine, LLC	2026-01-23	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)
3.0T AIR 32CH HNA Ge Healthcare Coils (Usa Instruments, Inc.) Cleared 2026-01-23 Registered with US (FDA)	Ge Healthcare Coils (Usa Instruments, Inc.)	2026-01-23	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)
BodyGuardian Remote Monitoring System (BGRMS v3.0) BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC. Cleared 2026-01-23 Registered with US (FDA)	BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.	2026-01-23	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)
Pneumo Dissector Hook ab medica sas Cleared 2026-01-23 Registered with US (FDA)	ab medica sas	2026-01-23	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)
Syntex Exam Gloves Basic Medical Technology, Inc. Cleared 2026-01-23 Registered with US (FDA)	Basic Medical Technology, Inc.	2026-01-23	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)
AccuContour 4.0 Manteia Technologies Co., Ltd. Cleared 2026-01-23 Registered with US (FDA)	Manteia Technologies Co., Ltd.	2026-01-23	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)
Evidence MultiSTAT DOA Urine MultiPlex Randox Laboratories Limited Cleared 2026-01-23 Registered with US (FDA)	Randox Laboratories Limited	2026-01-23	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)
MED-EL Cochlear Implant Med-El Corp. Cleared 2026-01-23 Registered with US (FDA)	Med-El Corp.	2026-01-23	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 Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) SHENZHEN RAINBOW TECHNOLOGY CO., LTD. Cleared 2026-01-23 Registered with US (FDA)	SHENZHEN RAINBOW TECHNOLOGY CO., LTD.	2026-01-23	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)
QuantiFERON®-TB Gold Test and QuantiFERON®-TB Gold Plus Test QIAGEN GmbH Cleared 2026-01-23 Registered with US (FDA)	QIAGEN GmbH	2026-01-23	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)
POINT Kinguide Agile Robotic Arm Surgical Stereotactic System Point Robotics MedTech, Inc. Cleared 2026-01-23 Registered with US (FDA)	Point Robotics MedTech, Inc.	2026-01-23	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)
New Day Skin Spray Silk Holdings, Inc. Cleared 2026-01-23 Registered with US (FDA)	Silk Holdings, Inc.	2026-01-23	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)
HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) Devicor Medical Products, Inc. Cleared 2026-01-23 Registered with US (FDA)	Devicor Medical Products, Inc.	2026-01-23	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)
DETOUR System Endologix, Inc. Cleared 2026-01-22 Registered with US (FDA)	Endologix, Inc.	2026-01-22	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)
Perin Health System (PHD80060-2) Perin Health Devices, LLC Cleared 2026-01-22 Registered with US (FDA)	Perin Health Devices, LLC	2026-01-22	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)
AV Vascular Philips Medical Systems Nederland BV Cleared 2026-01-22 Registered with US (FDA)	Philips Medical Systems Nederland BV	2026-01-22	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)
SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System Lima Corporate S.P.A. Cleared 2026-01-22 Registered with US (FDA)	Lima Corporate S.P.A.	2026-01-22	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)
Pump In Style® Pro+ Medela, Inc. Cleared 2026-01-22 Registered with US (FDA) Canada (Health Canada)	Medela, Inc.	2026-01-22	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)