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
HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Cleared 2026-01-05 Registered with US (FDA)	Samsung Medison Co., Ltd.	2026-01-05	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)
ChartCheck (RADCH V1.6) Radformation Cleared 2026-01-05 Registered with US (FDA)	Radformation	2026-01-05	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)
MONTAGE XT Cranial Cement Orthocon, LLC Cleared 2026-01-02 Registered with US (FDA)	Orthocon, LLC	2026-01-02	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)
Ready to use Nelaton Catheter Jamjoom Fullcare Corporation Cleared 2026-01-02 Registered with US (FDA)	Jamjoom Fullcare Corporation	2026-01-02	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)
FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit ZuriMED Technologies AG Cleared 2026-01-02 Registered with US (FDA)	ZuriMED Technologies AG	2026-01-02	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)
Mobility Scooter (BC-MS310) Ningbo Baichen Medical Devices Co., Ltd. Cleared 2026-01-02 Registered with US (FDA)	Ningbo Baichen Medical Devices Co., Ltd.	2026-01-02	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)
Genesis Sleep Neurofield, Inc. Cleared 2025-12-31 Registered with US (FDA)	Neurofield, Inc.	2025-12-31	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)
ASCENSION ORTHOPEDICS MCP Smith & Nephew, Inc. Cleared 2025-12-31 Registered with US (FDA)	Smith & Nephew, Inc.	2025-12-31	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)
MOLLI 2 System Stryker Endoscopy Cleared 2025-12-31 Registered with US (FDA)	Stryker Endoscopy	2025-12-31	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)
Proliv™Rx System Neurolief , Ltd. Cleared 2025-12-31 Registered with US (FDA)	Neurolief , Ltd.	2025-12-31	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)
Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) Arc Trauma, LLC Cleared 2025-12-31 Registered with US (FDA)	Arc Trauma, LLC	2025-12-31	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)
TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) Shenzhen Jiantuo Electronics Co., Ltd. Cleared 2025-12-31 Registered with US (FDA)	Shenzhen Jiantuo Electronics Co., Ltd.	2025-12-31	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)
Lipids Truvian Health Cleared 2025-12-30 Registered with US (FDA)	Truvian Health	2025-12-30	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)
AnyScan 3.0 NM Scanner Family Mediso Medical Imaging Systems Ltd Cleared 2025-12-30 Registered with US (FDA)	Mediso Medical Imaging Systems Ltd	2025-12-30	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)
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer Lucas Lifecare Cleared 2025-12-30 Registered with US (FDA)	Lucas Lifecare	2025-12-30	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)
Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm Arthrex, Inc. Cleared 2025-12-30 Registered with US (FDA)	Arthrex, Inc.	2025-12-30	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)
TruSPECT Processing Station Spectrum Dynamics Medical, Ltd. Cleared 2025-12-30 Registered with US (FDA)	Spectrum Dynamics Medical, Ltd.	2025-12-30	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)
Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) TECHNO-PATH MANUFACTURING LTD. Cleared 2025-12-30 Registered with US (FDA)	TECHNO-PATH MANUFACTURING LTD.	2025-12-30	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)
Celebrace Software Celebrace Cleared 2025-12-29 Registered with US (FDA)	Celebrace	2025-12-29	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)
Oxygen Concentrator (J10A) Foshan Kycare Medical Equipment Co., Ltd. Cleared 2025-12-29 Registered with US (FDA)	Foshan Kycare Medical Equipment Co., Ltd.	2025-12-29	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)
Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) Covidien Cleared 2025-12-29 Registered with US (FDA)	Covidien	2025-12-29	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)
Niti-S Biliary Stent; Niti-S Biliary Slim M Stent Taewoong Medical Co., Ltd. Cleared 2025-12-29 Registered with US (FDA)	Taewoong Medical Co., Ltd.	2025-12-29	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)
ZipToe™ Hammertoe Fusion System Toetal Solutions Cleared 2025-12-29 Registered with US (FDA)	Toetal Solutions	2025-12-29	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)
Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT Covidien Cleared 2025-12-29 Registered with US (FDA)	Covidien	2025-12-29	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)
Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) Shenzhen Fansizhe Science And Technology Co., Ltd. Cleared 2025-12-29 Registered with US (FDA)	Shenzhen Fansizhe Science And Technology Co., Ltd.	2025-12-29	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)
PICO-K Speclipse, Inc. Cleared 2025-12-24 Registered with US (FDA) AU (TGA) EU (EUDAMED)	Speclipse, Inc.	2025-12-24	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
Hair Regrowth Cap (Model: T-119-HRC) Light Tree Ventures Europe B.V. Cleared 2025-12-24 Registered with US (FDA)	Light Tree Ventures Europe B.V.	2025-12-24	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)
LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) SHENZHEN SAIDI LIGHT THERAPY TECHNOLOGY CO., LTD Cleared 2025-12-24 Registered with US (FDA)	SHENZHEN SAIDI LIGHT THERAPY TECHNOLOGY CO., LTD	2025-12-24	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)
Feather/numiere 05 06 07 (05) Heat IN A Click, LLC Cleared 2025-12-24 Registered with US (FDA)	Heat IN A Click, LLC	2025-12-24	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)
LIAISON NES FLU A/B, RSV & COVID-19 DiaSorin Molecular LLC Cleared 2025-12-23 Registered with US (FDA)	DiaSorin Molecular LLC	2025-12-23	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)
OsteoRemedies Hip Spacer System Osteoremedies, LLC Cleared 2025-12-23 Registered with US (FDA)	Osteoremedies, LLC	2025-12-23	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)
UpDoc Updoc, Inc. Cleared 2025-12-23 Registered with US (FDA)	Updoc, Inc.	2025-12-23	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)
Healgen URS Test Strips Healgen Scientific, LLC Cleared 2025-12-23 Registered with US (FDA)	Healgen Scientific, LLC	2025-12-23	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)
OrangeCAD Med Abutments OrangeCAD Med GmbH Cleared 2025-12-23 Registered with US (FDA)	OrangeCAD Med GmbH	2025-12-23	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)
Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) Shenzhen Siken 3D Technology Development Co., Ltd. Cleared 2025-12-23 Registered with US (FDA)	Shenzhen Siken 3D Technology Development Co., Ltd.	2025-12-23	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)
Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D) Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. Cleared 2025-12-23 Registered with US (FDA)	Linhejiacheng (Shenzhen) E-Commerce Co., Ltd.	2025-12-23	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)
Custom Abutments AS Medentika GMBH Cleared 2025-12-23 Registered with US (FDA)	Medentika GMBH	2025-12-23	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)
DUROLANE® Bioventus LLC Cleared 2025-12-23 Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA) EU (EUDAMED)	Bioventus LLC	2025-12-23	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
SYNOJOYNT Mesoblast Cleared 2025-12-23 Registered with US (FDA)	Mesoblast	2025-12-23	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)
GEN5™ and GEN5+™ 3.3mmD Dental Implants PARAGON IMPLANT MFG., LLC Cleared 2025-12-23 Registered with US (FDA)	PARAGON IMPLANT MFG., LLC	2025-12-23	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)
ART-Plan+ (v3.1.0) THERAPANACEA Cleared 2025-12-23 Registered with US (FDA)	THERAPANACEA	2025-12-23	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)
Philips Lumea IPL Philips Consumer Lifestyle Cleared 2025-12-23 Registered with US (FDA)	Philips Consumer Lifestyle	2025-12-23	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)
LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) DiaSorin, Inc. Cleared 2025-12-23 Registered with US (FDA)	DiaSorin, Inc.	2025-12-23	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)
NizPlant Dental Implant System PARAGON IMPLANT MFG., LLC Cleared 2025-12-23 Registered with US (FDA)	PARAGON IMPLANT MFG., LLC	2025-12-23	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)
UNITY DX (UDX) Cylite Pty. , Ltd. Cleared 2025-12-23 Registered with US (FDA)	Cylite Pty. , Ltd.	2025-12-23	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)
VarioSurg 4 NAKANISHI INC. Cleared 2025-12-23 Registered with US (FDA)	NAKANISHI INC.	2025-12-23	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)
Electric Scooter (S202572J, S2060, M2089, S2050) Guangdong Prestige Technology Co, Ltd Cleared 2025-12-23 Registered with US (FDA)	Guangdong Prestige Technology Co, Ltd	2025-12-23	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)
VEINOPLUS Back Dynapulse Medical Cleared 2025-12-23 Registered with US (FDA)	Dynapulse Medical	2025-12-23	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)
TENS&EMS (HZ9151B, HZ9151C, HZ9151D) Hong Qiangxing (Shenzhen) Electronics Limited Cleared 2025-12-23 Registered with US (FDA)	Hong Qiangxing (Shenzhen) Electronics Limited	2025-12-23	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)
Sim&Size Sim&Cure Cleared 2025-12-23 Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA) EU (EUDAMED)	Sim&Cure	2025-12-23	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)