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.

3,665 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
BIORES Dental Implant System Chengdu Besmile Medical Technology Co., Ltd. Cleared 2026-02-02 Registered with US (FDA)	Chengdu Besmile Medical Technology Co., Ltd.	2026-02-02	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)
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) Merit Medical Ireland, Ltd. Cleared 2026-01-31 Registered with US (FDA)	Merit Medical Ireland, Ltd.	2026-01-31	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)
Clungene RSV Antigen Rapid Test Hangzhou Clongene Biotech Co., Ltd. Cleared 2026-01-30 Registered with US (FDA)	Hangzhou Clongene Biotech Co., Ltd.	2026-01-30	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 End Tape Hood Shanghai SeeGen Photoelectric Technology Co., Ltd. Cleared 2026-01-30 Registered with US (FDA)	Shanghai SeeGen Photoelectric Technology Co., Ltd.	2026-01-30	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)
RevealAI-Lung Precision Medical Ventures Inc dba RevealDx Cleared 2026-01-30 Registered with US (FDA) UK (MHRA)	Precision Medical Ventures Inc dba RevealDx	2026-01-30	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) Shenzhen Peninsula Medical Co., Ltd. Cleared 2026-01-30 Registered with US (FDA)	Shenzhen Peninsula Medical Co., Ltd.	2026-01-30	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)
BruxZir® Shaded 16 PLUS Prismatik Dentalcraft, Inc. Cleared 2026-01-30 Registered with US (FDA)	Prismatik Dentalcraft, Inc.	2026-01-30	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)
Boston PICO (Boston PICO) Boston Aesthetics, Inc. Cleared 2026-01-30 Registered with US (FDA)	Boston Aesthetics, Inc.	2026-01-30	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)
SQUID Liquid Embolic Agent (LEA) Balt USA, LLC Cleared 2026-01-30 Registered with US (FDA)	Balt USA, LLC	2026-01-30	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)
Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) Asistan Medikal Cleared 2026-01-30 Registered with US (FDA)	Asistan Medikal	2026-01-30	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)
BAROguard Donor Lung Preservation System Paragonix Technologies, Inc. Cleared 2026-01-30 Registered with US (FDA)	Paragonix Technologies, Inc.	2026-01-30	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 & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) Shenzhen Jianchao Intelligent Technology Co., Ltd. Cleared 2026-01-30 Registered with US (FDA)	Shenzhen Jianchao Intelligent Technology Co., Ltd.	2026-01-30	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)
Dual Stage Venous Cannulae Sorin Group Italia S.R.L. Cleared 2026-01-30 Registered with US (FDA)	Sorin Group Italia S.R.L.	2026-01-30	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)
Motor Handpiece and Control Unit (SDI10) SAESHIN PRECISION CO.,LTD. Cleared 2026-01-30 Registered with US (FDA)	SAESHIN PRECISION CO.,LTD.	2026-01-30	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-T580) 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)
Electric Scooter (DDF100) Zhejiang Nysin Medical Co., Ltd. Cleared 2026-01-29 Registered with US (FDA)	Zhejiang Nysin Medical 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)
Multi-Unit DAS System Talladium Espana, SL Cleared 2026-01-29 Registered with US (FDA)	Talladium Espana, SL	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)
Manual Wheelchair (W50) Jiangsu Jumao X-Care Medical Equipment Co.,Ltd Cleared 2026-01-29 Registered with US (FDA)	Jiangsu Jumao X-Care Medical Equipment 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)
Labcorp Fentanyl Urine Visual Test Medtox Diagnostics, Inc. Cleared 2026-01-29 Registered with US (FDA)	Medtox Diagnostics, 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)
EK MULTI ANGLED 30 ABUTMENT Hiossen, Inc. Cleared 2026-01-29 Registered with US (FDA)	Hiossen, 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)
Medical Shaver System (Morcellator) (YSB-IIIA) Hangzhou Hawk Optical Electronic Instruments Co.,Ltd. Cleared 2026-01-29 Registered with US (FDA)	Hangzhou Hawk Optical Electronic Instruments 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)
ACTIVL ARTIFICIAL DISC Highridge Medical LLC Cleared 2026-01-29 Registered with US (FDA)	Highridge Medical 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)
Neurophet AQUA AD Plus Neurophet., Inc. Cleared 2026-01-29 Registered with US (FDA)	Neurophet., 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)
EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits HR HealthCare Cleared 2026-01-29 Registered with US (FDA)	HR HealthCare	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)
Surgical Reality Viewer MedicalVR BV Cleared 2026-01-29 Registered with US (FDA)	MedicalVR BV	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)
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)
FLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW) PTCA CATHETERS 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)