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
ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable Acist Medical Systems Cleared 2026-05-13 Registered with US (FDA)	Acist Medical Systems	2026-05-13	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)
OPTIMIZER Smart and Smart Mini Impulse Dynamics (Usa), Inc. Cleared 2026-05-13 Registered with US (FDA)	Impulse Dynamics (Usa), Inc.	2026-05-13	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 (Y207BL) Jiangsu Intco Medical Products Co., Ltd. Cleared 2026-05-13 Registered with US (FDA)	Jiangsu Intco Medical Products Co., Ltd.	2026-05-13	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)
Automatic Micro Needle System (CODE-X) Woorhi Mechatronics Co Ltd Cleared 2026-05-13 Registered with US (FDA)	Woorhi Mechatronics Co Ltd	2026-05-13	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 Breast Pump (HL-3058 II Pro) Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. Cleared 2026-05-13 Registered with US (FDA)	Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.	2026-05-13	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)
Portable Neuromodulation Stimulator (PoNS) HELIUS MEDICAL, INC. Cleared 2026-05-13 Registered with US (FDA)	HELIUS MEDICAL, INC.	2026-05-13	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)
MENTOR Saline-Filled and Spectrum™ Breast Implants Mentor Worldwide, LLC Cleared 2026-05-12 Registered with US (FDA)	Mentor Worldwide, LLC	2026-05-12	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)
Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant Promimic AB Cleared 2026-05-12 Registered with US (FDA)	Promimic AB	2026-05-12	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)
CellDx-Tissue Datar Cancer Genetics Private Limited Cleared 2026-05-12 Registered with US (FDA)	Datar Cancer Genetics Private Limited	2026-05-12	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)
Senhance Ultrasonic System Asensus Surgical, Inc. Cleared 2026-05-12 Registered with US (FDA)	Asensus Surgical, Inc.	2026-05-12	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)
TOUCH® CMC 1 Prosthesis Keri Medical SA Cleared 2026-05-12 Registered with US (FDA) AU (TGA)	Keri Medical SA	2026-05-12	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Bellafill® Dermal Filler TIGER AESTHETICS MEDICAL, LLC Cleared 2026-05-12 Registered with US (FDA)	TIGER AESTHETICS MEDICAL, LLC	2026-05-12	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)
Endurant™ II/IIs Stent Graft System Medtronic Vascular Cleared 2026-05-12 Registered with US (FDA)	Medtronic Vascular	2026-05-12	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)
BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) Hindernis DE Mexico, S.A.P.I. DE C.V. Cleared 2026-05-12 Registered with US (FDA)	Hindernis DE Mexico, S.A.P.I. DE C.V.	2026-05-12	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)
VersaLift Expandable System Life Spine, LLC Cleared 2026-05-12 Registered with US (FDA)	Life Spine, LLC	2026-05-12	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)
RHA Redensity® Eye Lido; RHA Redensity® Eye Teoxane S.A. Cleared 2026-05-12 Registered with US (FDA)	Teoxane S.A.	2026-05-12	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)
CorVision® (91-205-Z0014) CorVent® Medical, Inc. Cleared 2026-05-12 Registered with US (FDA)	CorVent® Medical, Inc.	2026-05-12	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 nasal aspirator (BC027, BC030, BC033, BC035, BC035B) SHENZHEN KINGBOOM TECHNOLOGY CO., LTD Cleared 2026-05-12 Registered with US (FDA)	SHENZHEN KINGBOOM TECHNOLOGY CO., LTD	2026-05-12	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)
Promisemed VeriEcto Automatic Biopsy Needles Promisemed Hangzhou Meditech Co., Ltd. Cleared 2026-05-12 Registered with US (FDA)	Promisemed Hangzhou Meditech Co., Ltd.	2026-05-12	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)
OSTEOMNI SPINAL CAGES SYSTEM OSTEOMNI, Inc. Cleared 2026-05-12 Registered with US (FDA)	OSTEOMNI, Inc.	2026-05-12	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)
Rayvolve Azmed Sas Cleared 2026-05-12 Registered with US (FDA) UK (MHRA) AU (TGA) EU (EUDAMED)	Azmed Sas	2026-05-12	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
myLEDmask 2 (MJ-144) Light Tree Ventures Europe B.V. Cleared 2026-05-12 Registered with US (FDA)	Light Tree Ventures Europe B.V.	2026-05-12	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)
CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465) Verathon Medical (Canada) Ulc Cleared 2026-05-11 Registered with US (FDA)	Verathon Medical (Canada) Ulc	2026-05-11	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)
Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Cleared 2026-05-11 Registered with US (FDA)	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2026-05-11	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) Endo-Perio Velmeni, Inc. Cleared 2026-05-11 Registered with US (FDA)	Velmeni, Inc.	2026-05-11	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)
Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT) Shenzhen IMDK Medical Technology Co, Ltd Cleared 2026-05-11 Registered with US (FDA)	Shenzhen IMDK Medical Technology Co, Ltd	2026-05-11	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)
SAYA 86 Radial Access Guide Catheter Asahi Intecc Co., Ltd. Cleared 2026-05-11 Registered with US (FDA)	Asahi Intecc Co., Ltd.	2026-05-11	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)
HardyDisk AST Gepotidacin 10µg (GEP10) Hardy Diagnostics Cleared 2026-05-11 Registered with US (FDA)	Hardy Diagnostics	2026-05-11	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)
ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) Abbott Laboratories Cleared 2026-05-11 Registered with US (FDA)	Abbott Laboratories	2026-05-11	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 SHINING (PICO-K; PICOFY) Speclipse, Inc. Cleared 2026-05-11 Registered with US (FDA)	Speclipse, Inc.	2026-05-11	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 Core Vericom Co., Ltd. Cleared 2026-05-11 Registered with US (FDA)	Vericom Co., Ltd.	2026-05-11	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)
Pytheas Your Guided Trajectory PYTHEAS NAVIGATION SAS Cleared 2026-05-11 Registered with US (FDA) UK (MHRA)	PYTHEAS NAVIGATION SAS	2026-05-11	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Protable Phlegm Suction Unit (JMA D01) Jiangsu Jumao X-Care Medical Equipment Co.,Ltd Cleared 2026-05-11 Registered with US (FDA)	Jiangsu Jumao X-Care Medical Equipment Co.,Ltd	2026-05-11	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 IM free PSA II (fPSAII) Siemens Healthcare Diagnostics Cleared 2026-05-11 Registered with US (FDA) UK (MHRA)	Siemens Healthcare Diagnostics	2026-05-11	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm) Ethicon Endo-Surgery, Inc. Cleared 2026-05-11 Registered with US (FDA)	Ethicon Endo-Surgery, Inc.	2026-05-11	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)
Avitene™ Flowable Collagen Hemostat Davol Inc., Sub. C. R. Bard, Inc. Cleared 2026-05-11 Registered with US (FDA)	Davol Inc., Sub. C. R. Bard, Inc.	2026-05-11	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)
ADVIA Centaur AFP and Atellica IM Alpha Fetoprotein (AFP) Siemens Healthcare Diagnostics Cleared 2026-05-11 Registered with US (FDA)	Siemens Healthcare Diagnostics	2026-05-11	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 Trocars with Valve Seals Karl Storz SE & CO.KG Cleared 2026-05-11 Registered with US (FDA)	Karl Storz SE & CO.KG	2026-05-11	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)
MENTOR™ MemoryGel™ Enhance Breast Implants Mentor Corp. Cleared 2026-05-11 Registered with US (FDA)	Mentor Corp.	2026-05-11	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)
aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system Carlsmed, Inc. Cleared 2026-05-09 Registered with US (FDA)	Carlsmed, Inc.	2026-05-09	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)
Avanti Distal Elbow ORIF System Avanti Orthopaedics, Inc. Cleared 2026-05-09 Registered with US (FDA)	Avanti Orthopaedics, Inc.	2026-05-09	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)
Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) Elde Medikal Sanayi ve Ticaret Anonim Sirketi Cleared 2026-05-08 Registered with US (FDA)	Elde Medikal Sanayi ve Ticaret Anonim Sirketi	2026-05-08	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)
Revanesse Versa / Revanesse Versa+ (with lidocaine) / Revanesse Lips+ (with lidocaine) Prollenium Medical Technologies, Inc. Cleared 2026-05-08 Registered with US (FDA)	Prollenium Medical Technologies, Inc.	2026-05-08	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)
MiroCam Capsule Endoscope System Intromedic Co., Ltd. Cleared 2026-05-08 Registered with US (FDA) UK (MHRA) AU (TGA) EU (EUDAMED)	Intromedic Co., Ltd.	2026-05-08	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
HipGuide (V 1.0.0.0) Orthopedic Driven Imaging, LLC Cleared 2026-05-08 Registered with US (FDA)	Orthopedic Driven Imaging, LLC	2026-05-08	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)
LingOral Dental Design System Hangzhou ChohoTech Co., Ltd Cleared 2026-05-08 Registered with US (FDA)	Hangzhou ChohoTech Co., Ltd	2026-05-08	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)
GORE® CARDIOFORM Septal Occluder W. L. Gore and Associates, Inc. Cleared 2026-05-08 Registered with US (FDA) UK (MHRA) AU (TGA)	W. L. Gore and Associates, Inc.	2026-05-08	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Arthrex Beaming System Arthrex, Inc. Cleared 2026-05-08 Registered with US (FDA)	Arthrex, Inc.	2026-05-08	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)
AerFrame Patient Immobilization System (AFPIS) Stabilix, LLC Cleared 2026-05-08 Registered with US (FDA)	Stabilix, LLC	2026-05-08	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)
Modius Spero Neurovalens , Ltd. Cleared 2026-05-08 Registered with US (FDA)	Neurovalens , Ltd.	2026-05-08	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)