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.

3,686 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
Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 Thermo Fisher Scientific (Oxoid Ltd.) Cleared 2026-07-24 Registered with US (FDA)	Thermo Fisher Scientific (Oxoid Ltd.)	2026-07-24	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)
Careflux H60;Careflux H70;Careflux V500 Fresenius Medical Care Renal Therapies Group, LLC Cleared 2026-07-24 Registered with US (FDA)	Fresenius Medical Care Renal Therapies Group, LLC	2026-07-24	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)
OBSIDIO™ Conformable Embolic Boston Scientific Corp Cleared 2026-07-24 Registered with US (FDA)	Boston Scientific Corp	2026-07-24	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)
VERAFEYE Imaging Catheter (VF-VIC-002) Luma Vision Limited Cleared 2026-07-24 Registered with US (FDA)	Luma Vision Limited	2026-07-24	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)
RemunityPRO+ Pump for Remodulin® (treprostinil) Injection Deka R&D Corp Cleared 2026-07-24 Registered with US (FDA)	Deka R&D Corp	2026-07-24	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)
Atellica CH Acetaminophen 2 (ACTM) Siemens Healthcare Diagnostics Cleared 2026-07-24 Registered with US (FDA)	Siemens Healthcare Diagnostics	2026-07-24	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)
EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes Cook Ireland, Ltd. Cleared 2026-07-24 Registered with US (FDA)	Cook Ireland, Ltd.	2026-07-24	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)
Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P GE Medical Systems Information Technologies, Inc Cleared 2026-07-24 Registered with US (FDA)	GE Medical Systems Information Technologies, Inc	2026-07-24	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)
EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device) Medical Impact Cleared 2026-07-24 Registered with US (FDA)	Medical Impact	2026-07-24	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)
QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) MANTIZ Co., Ltd. Cleared 2026-07-24 Registered with US (FDA)	MANTIZ Co., Ltd.	2026-07-24	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)
GEN 4 JOY Wheelchair Free Wheelchair Mission Cleared 2026-07-24 Registered with US (FDA)	Free Wheelchair Mission	2026-07-24	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)
TMINI™ Miniature Robotic System THINK Surgical, Inc. Cleared 2026-07-24 Registered with US (FDA)	THINK Surgical, Inc.	2026-07-24	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)
LumenCare Azure Nucletron Corp. Cleared 2026-07-24 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Nucletron Corp.	2026-07-24	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
FARADRIVE™ Steerable Sheath (M004PF21M402) Boston Scientific Corp Cleared 2026-07-24 Registered with US (FDA)	Boston Scientific Corp	2026-07-24	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)
SwiftMR Airs Medical, Inc. Cleared 2026-07-24 Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA) EU (EUDAMED)	Airs Medical, Inc.	2026-07-24	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T Philips Medical Systems Nederland BV Cleared 2026-07-24 Registered with US (FDA)	Philips Medical Systems Nederland BV	2026-07-24	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)
Gelsyn-3 Ibsa Institut Biochimique SA Cleared 2026-07-24 Registered with US (FDA)	Ibsa Institut Biochimique SA	2026-07-24	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)
DIANA ROPCA Cleared 2026-07-24 Registered with US (FDA) EU (EUDAMED)	ROPCA	2026-07-24	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Accuro® 3S Needle Guide Kit Rivanna Medical, LLC Cleared 2026-07-24 Registered with US (FDA)	Rivanna Medical, LLC	2026-07-24	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)
PerfusiX-Imaging LIMIS Development B.V. Cleared 2026-07-24 Registered with US (FDA)	LIMIS Development B.V.	2026-07-24	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)
NEXUS Aortic Arch Stent Graft System Endospan Ltd Cleared 2026-07-24 Registered with US (FDA) UK (MHRA)	Endospan Ltd	2026-07-24	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Accuro 3S Rivanna Medical, LLC Cleared 2026-07-24 Registered with US (FDA)	Rivanna Medical, LLC	2026-07-24	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)
VELMENI for DENTISTS (V4D) 3D Velmeni, Inc. Cleared 2026-07-23 Registered with US (FDA)	Velmeni, Inc.	2026-07-23	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)
Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) Microlife Corp. Cleared 2026-07-23 Registered with US (FDA)	Microlife Corp.	2026-07-23	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)
Dental Cone-beam Computed Tomography (mDX-15P Series) Hefei Meyer Optoelectronic Technology Inc Cleared 2026-07-23 Registered with US (FDA)	Hefei Meyer Optoelectronic Technology Inc	2026-07-23	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)
S-ICD EMBLEM™ GEN 2 (A209); S-ICD EMBLEM™ MRI (A219) Boston Scientific Corp Cleared 2026-07-23 Registered with US (FDA)	Boston Scientific Corp	2026-07-23	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)
FACEGYM Pro Device (HD-109) SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD. Cleared 2026-07-23 Registered with US (FDA)	SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD.	2026-07-23	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)
RXiBreeze PAP System (RXiBreeze 20C) RESVENT MEDICAL TECHNOLOGY CO., LTD. Cleared 2026-07-23 Registered with US (FDA)	RESVENT MEDICAL TECHNOLOGY CO., LTD.	2026-07-23	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)
SENSARTM 1-Piece IOL, AAB00; TECNISTM 1-Piece IOL with TECNIS Simplicity™ Delivery System, DCB00; TECNISTM 1-Piece OptiB Johnson&Johnson Surgical Vision Inc Cleared 2026-07-23 Registered with US (FDA) AU (TGA)	Johnson&Johnson Surgical Vision Inc	2026-07-23	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
VALITUDE™ CRT-P IS1 EL (U125); VALITUDE™ CRT-P IS4 EL (U128); VISIONIST™ CRT-P IS1 EL (U225); VISIONIST™ CRT-P LV1 EL (U Guidant Corp. Cleared 2026-07-23 Registered with US (FDA)	Guidant Corp.	2026-07-23	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)
Alinity m HR HPV Assay Abbott Molecular, Inc. Cleared 2026-07-23 Registered with US (FDA)	Abbott Molecular, Inc.	2026-07-23	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)
Perfadex Plus Xvivo Perfusion AB Cleared 2026-07-23 Registered with US (FDA) UK (MHRA) AU (TGA)	Xvivo Perfusion AB	2026-07-23	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
3d Cage Cervical Fims Co., Ltd. Cleared 2026-07-23 Registered with US (FDA)	Fims Co., Ltd.	2026-07-23	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)
ESSENTIO™ MRI SR SL (L110); ESSENTIO™ MRI DR SL (L111); ESSENTIO™ MRI DR EL (L131); PROPONENT™ MRI SR SL (L210); PROPONE Boston Scientific Corp Cleared 2026-07-23 Registered with US (FDA)	Boston Scientific Corp	2026-07-23	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)
ESSENTIO™ SR SL (L100); ESSENTIO™ DR SL (L101); ESSENTIO™ DR EL (L121); PROPONENT™ SR SL (L200); PROPONENT™ DR SL (L201) Boston Scientific Corp Cleared 2026-07-23 Registered with US (FDA)	Boston Scientific Corp	2026-07-23	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)
CORE 300 Digital Stethoscope Eko Health, Inc Cleared 2026-07-23 Registered with US (FDA) Canada (Health Canada)	Eko Health, Inc	2026-07-23	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system Esonic Technology (Wuhan) Co., Ltd. Cleared 2026-07-23 Registered with US (FDA)	Esonic Technology (Wuhan) Co., Ltd.	2026-07-23	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)
Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) Beijing Konted Medical Technology Co.,Ltd Cleared 2026-07-23 Registered with US (FDA)	Beijing Konted Medical Technology Co.,Ltd	2026-07-23	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)
ImageGrid StreamVue CANDELIS INC. Cleared 2026-07-23 Registered with US (FDA) Canada (Health Canada)	CANDELIS INC.	2026-07-23	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) Guangzhou Daxin Health Technology Co., Ltd. Cleared 2026-07-23 Registered with US (FDA)	Guangzhou Daxin Health Technology Co., Ltd.	2026-07-23	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)
Klassic Infection Spacer System Total Joint Orthopedics, Inc. Cleared 2026-07-23 Registered with US (FDA)	Total Joint Orthopedics, Inc.	2026-07-23	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)
Total Flow Medical Femoral Arterial (TFA) cannula Total Flow Medical Limited Cleared 2026-07-23 Registered with US (FDA)	Total Flow Medical Limited	2026-07-23	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)
TRUE METRIX Self Monitoring Blood Glucose System Trividia Health, Inc Cleared 2026-07-23 Registered with US (FDA)	Trividia Health, Inc	2026-07-23	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)
Gepotidacin GEP 10 µg Liofilchem S. R. L. Cleared 2026-07-23 Registered with US (FDA) EU (EUDAMED)	Liofilchem S. R. L.	2026-07-23	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Lacrosse NSE ALPHA Coronary Dilatation Catheter NIPRO VASCULAR CORPORATION Cleared 2026-07-22 Registered with US (FDA) UK (MHRA) AU (TGA) EU (EUDAMED)	NIPRO VASCULAR CORPORATION	2026-07-22	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
AlphaTriPart - Monopolar MIC Instruments Gimmi GmbH Cleared 2026-07-22 Registered with US (FDA)	Gimmi GmbH	2026-07-22	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)
E3D™-C Interbody System Evolution Spine, LLC Cleared 2026-07-22 Registered with US (FDA) AU (TGA)	Evolution Spine, LLC	2026-07-22	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
NanoZoomer S540MD Slide Scanner System Hamamatsu Photonics K.K. Cleared 2026-07-22 Registered with US (FDA)	Hamamatsu Photonics K.K.	2026-07-22	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)
HiResolution™ Bionic Ear System Advanced Bionics Cleared 2026-07-22 Registered with US (FDA) AU (TGA)	Advanced Bionics	2026-07-22	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
STEDI Scan Device Stroke DX Cleared 2026-07-22 Registered with US (FDA)	Stroke DX	2026-07-22	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)