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.

3,708 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
SALGINA 2.5mm Distal Radius System Bonebridge AG Cleared 2026-06-26 Registered with US (FDA)	Bonebridge AG	2026-06-26	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)
MammoScreen® (5) Therapixel Cleared 2026-06-26 Registered with US (FDA)	Therapixel	2026-06-26	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)
VERTICALE Navigation Instruments Silony Medical GmbH Cleared 2026-06-26 Registered with US (FDA)	Silony Medical GmbH	2026-06-26	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)
AMDS Hybrid Prosthesis Artivion, Inc. Cleared 2026-06-26 Registered with US (FDA)	Artivion, Inc.	2026-06-26	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)
SimplGuide Pendracare Cleared 2026-06-25 Registered with US (FDA)	Pendracare	2026-06-25	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)
IntraOp Alignment System; CONTOUR3D Bending System Alphatec Spine, Inc. Cleared 2026-06-25 Registered with US (FDA)	Alphatec Spine, Inc.	2026-06-25	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)
TriClip Delivery System Abbott Medical Cleared 2026-06-25 Registered with US (FDA) AU (TGA)	Abbott Medical	2026-06-25	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
DVT Garment Vistar Medical Supplies Co,Ltd Cleared 2026-06-25 Registered with US (FDA) EU (EUDAMED)	Vistar Medical Supplies Co,Ltd	2026-06-25	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
MiPACS V5 (1.0.0) Apryse Software Corp Cleared 2026-06-25 Registered with US (FDA)	Apryse Software Corp	2026-06-25	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)
GYNECARE INTERCEED™ Absorbable Adhesion Barrier ETHICON LLC Cleared 2026-06-25 Registered with US (FDA) UK (MHRA) AU (TGA)	ETHICON LLC	2026-06-25	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture ETHICON LLC Cleared 2026-06-25 Registered with US (FDA)	ETHICON LLC	2026-06-25	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)
Jabra Enhance Select Self-fit (Jabra Enhance Select 550) GN Hearing A/S Cleared 2026-06-25 Registered with US (FDA)	GN Hearing A/S	2026-06-25	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)
syngo.CT Coronary Cockpit Siemens Medical Solutions USA, Inc. Cleared 2026-06-25 Registered with US (FDA)	Siemens Medical Solutions USA, Inc.	2026-06-25	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)
ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754) Longeviti Neuro Solutions, LLC Cleared 2026-06-25 Registered with US (FDA)	Longeviti Neuro Solutions, LLC	2026-06-25	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)
EliA CTD 13 Screen Phadia AB Cleared 2026-06-25 Registered with US (FDA)	Phadia AB	2026-06-25	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)
A5 Anesthesia System (A5); A7 Anesthesia System (A7) Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Cleared 2026-06-25 Registered with US (FDA)	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2026-06-25	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 Sterile VAL and VAL KreuLock™ Compression Screw System Arthrex, Inc. Cleared 2026-06-25 Registered with US (FDA)	Arthrex, Inc.	2026-06-25	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)
UNIQA Dental Implants System UNIQA DENTAL LTD Cleared 2026-06-25 Registered with US (FDA)	UNIQA DENTAL LTD	2026-06-25	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)
Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) Weyo Surgical Technology Ltd. Cleared 2026-06-25 Registered with US (FDA)	Weyo Surgical Technology Ltd.	2026-06-25	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)
iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) Neuralytix, LLC Cleared 2026-06-25 Registered with US (FDA)	Neuralytix, LLC	2026-06-25	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)
G-Series Grind Guard ASESSO HEALTH, Inc. Cleared 2026-06-25 Registered with US (FDA)	ASESSO HEALTH, Inc.	2026-06-25	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)
MitraClip™ G4 Clip Delivery System, MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System Abbott Medical Cleared 2026-06-25 Registered with US (FDA) AU (TGA)	Abbott Medical	2026-06-25	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) Seers Technology Co., Ltd. Cleared 2026-06-25 Registered with US (FDA)	Seers Technology Co., Ltd.	2026-06-25	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)
VELYS™ Robotic-Assisted Solution Depuy Ireland UC Cleared 2026-06-25 Registered with US (FDA) Canada (Health Canada)	Depuy Ireland UC	2026-06-25	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
ATTUNE Total Knee System; ATTUNE Cementless Knee System Depuy Ireland UC Cleared 2026-06-25 Registered with US (FDA)	Depuy Ireland UC	2026-06-25	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)
BedDot (G1) Intelligent Dots, LLC Cleared 2026-06-25 Registered with US (FDA)	Intelligent Dots, LLC	2026-06-25	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)
Wearable breast pump (QY-101, QY-102, QY-108) Shenzhen Qinyi Electronic Technology Co., Ltd. Cleared 2026-06-25 Registered with US (FDA)	Shenzhen Qinyi Electronic Technology Co., Ltd.	2026-06-25	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)
SilverCeuticals® Antimicrobial Wound Gel Silverceuticals, Inc. Cleared 2026-06-24 Registered with US (FDA)	Silverceuticals, Inc.	2026-06-24	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)
HD Camera Head OLYMPUS CH-S200-08-LB Olympus Medical Systems Corporation Cleared 2026-06-24 Registered with US (FDA)	Olympus Medical Systems Corporation	2026-06-24	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)
Target Xtra Detachable Coil Stryker Neurovscular Cleared 2026-06-24 Registered with US (FDA)	Stryker Neurovscular	2026-06-24	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)
CapSureFix Novus Lead (5076), CapSureFix Novus Lead (4076), Vitatron Crystalline Active Fixation Lead (ICQ09B) Medtronic, Inc Cleared 2026-06-24 Registered with US (FDA)	Medtronic, Inc	2026-06-24	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)
CapSure Sense Lead (4074), CapSure Sense Lead (4574), Vitatron Crystalline Lead (ICM09B, ICM09JB) Medtronic Cardiac Rhythm Disease Management Cleared 2026-06-24 Registered with US (FDA)	Medtronic Cardiac Rhythm Disease Management	2026-06-24	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)
Endoform Dermal Template Aroa Biosurgery Cleared 2026-06-24 Registered with US (FDA) Canada (Health Canada)	Aroa Biosurgery	2026-06-24	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Enhanced Boundary for PCCT Ge Medical Systems, Inc. Cleared 2026-06-24 Registered with US (FDA)	Ge Medical Systems, Inc.	2026-06-24	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)
TOUCH® CMC 1 Prosthesis Keri Medical SA Cleared 2026-06-24 Registered with US (FDA) AU (TGA)	Keri Medical SA	2026-06-24	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Attain Ability Lead (4196, 4296), Attain Ability Lead (4396), Attain Performa Lead (4298, 4398, 4598), Attain Stability Medtronic, Inc Cleared 2026-06-24 Registered with US (FDA)	Medtronic, Inc	2026-06-24	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)
Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) Hangzhou Jimushi Meditech Co., Ltd. Cleared 2026-06-24 Registered with US (FDA)	Hangzhou Jimushi Meditech Co., Ltd.	2026-06-24	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)
Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution Sw Technologies, Inc. Cleared 2026-06-24 Registered with US (FDA)	Sw Technologies, Inc.	2026-06-24	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)
Ceribell Neurology Review Software Ceribell, Inc. Cleared 2026-06-24 Registered with US (FDA)	Ceribell, Inc.	2026-06-24	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)
Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) Shanghai Waylong Intelligent Technology Co.,Ltd Cleared 2026-06-24 Registered with US (FDA)	Shanghai Waylong Intelligent Technology Co.,Ltd	2026-06-24	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 Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus DiaSorin, Inc. Cleared 2026-06-24 Registered with US (FDA)	DiaSorin, Inc.	2026-06-24	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)
Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019 Hangzhou AGS MedTech Co., Ltd. Cleared 2026-06-24 Registered with US (FDA)	Hangzhou AGS MedTech Co., Ltd.	2026-06-24	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)
CLEAR™ Aspiration System Insera Therapeutics, Inc. Cleared 2026-06-24 Registered with US (FDA)	Insera Therapeutics, Inc.	2026-06-24	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)
Concerto Versa™ Detachable Coil Medtronic, Inc Cleared 2026-06-24 Registered with US (FDA)	Medtronic, Inc	2026-06-24	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)
Microdacyn Wound Irrigation Solution Sonoma Pharmaceuticals Cleared 2026-06-24 Registered with US (FDA)	Sonoma Pharmaceuticals	2026-06-24	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)
AMSCO 700 Steam Sterilizer STERIS SAS Cleared 2026-06-24 Registered with US (FDA)	STERIS SAS	2026-06-24	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)
ConvaVAC™ Negative Pressure Wound Therapy System Convatec Limited, Gdc Building Cleared 2026-06-24 Registered with US (FDA)	Convatec Limited, Gdc Building	2026-06-24	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)
CURASYS 2 (EMDN0003) CG Bio Co., Ltd. Cleared 2026-06-23 Registered with US (FDA)	CG Bio Co., Ltd.	2026-06-23	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)
AquaBeam Robotic System Procept Biorobotics, Corporation Cleared 2026-06-23 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	Procept Biorobotics, Corporation	2026-06-23	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) Integra Lifesciences Production Corporation Cleared 2026-06-23 Registered with US (FDA)	Integra Lifesciences Production Corporation	2026-06-23	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)