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
DiamondTemp Catheter, Unidirectional, Small Curve, DiamondTemp Catheter, Unidirectional, Large Curve, DiamondTemp Cathet Medtronic, Inc Cleared 2025-10-10 Registered with US (FDA)	Medtronic, Inc	2025-10-10	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)
Eleganz IM Threaded Nail System (IM Threaded Nail System) Dev4 Cleared 2025-10-10 Registered with US (FDA)	Dev4	2025-10-10	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 HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test DiaSorin, Inc. Cleared 2025-10-10 Registered with US (FDA)	DiaSorin, Inc.	2025-10-10	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)
RelayPlus Thoracic Stent-Graft System Bolton Medical, Inc. Cleared 2025-10-10 Registered with US (FDA) UK (MHRA)	Bolton Medical, Inc.	2025-10-10	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Verruca-Freeze H Plus CRYOSURGERY, INC. Cleared 2025-10-10 Registered with US (FDA)	CRYOSURGERY, INC.	2025-10-10	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)
On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System Acon Laboratories, Inc. Cleared 2025-10-10 Registered with US (FDA)	Acon Laboratories, Inc.	2025-10-10	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)
DeGen Medical Latitude-C AM Cervical Interbody Fusion System Degen Medical Cleared 2025-10-10 Registered with US (FDA)	Degen Medical	2025-10-10	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)
Collagen Wound Dressing Winner Medical Co, Ltd Cleared 2025-10-10 Registered with US (FDA)	Winner Medical Co, Ltd	2025-10-10	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)
DIASAFEplusUS (F00013010) Fresenius Medical Care Renal Therapies Group, LLC Cleared 2025-10-09 Registered with US (FDA)	Fresenius Medical Care Renal Therapies Group, LLC	2025-10-09	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)
Invisalign Specifix Attachment System Align Technology Ltd Cleared 2025-10-09 Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA) EU (EUDAMED)	Align Technology Ltd	2025-10-09	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS COTTON HIGH TECH, S.L. Cleared 2025-10-09 Registered with US (FDA)	COTTON HIGH TECH, S.L.	2025-10-09	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)
VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup Advin Biotech Cleared 2025-10-09 Registered with US (FDA)	Advin Biotech	2025-10-09	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)
Facial & Body Beauty Device (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 2025-10-09 Registered with US (FDA)	Shenzhen Jianchao Intelligent Technology Co., Ltd.	2025-10-09	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)
ORA Method LED Gua Sha (GS-04) SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD. Cleared 2025-10-09 Registered with US (FDA)	SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD.	2025-10-09	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)
cleadew GP hydra one Ophtecs Corporation Cleared 2025-10-09 Registered with US (FDA) EU (EUDAMED)	Ophtecs Corporation	2025-10-09	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) NIHON KOHDEN CORPORATION Cleared 2025-10-09 Registered with US (FDA)	NIHON KOHDEN CORPORATION	2025-10-09	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)
Lux HD 2530 detector (Lux HD 2530) Iray Imaging Technology (Haining) Limited Cleared 2025-10-09 Registered with US (FDA)	Iray Imaging Technology (Haining) Limited	2025-10-09	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)
Orca Air/Water and Suction Valves Boston Scientific Corp Cleared 2025-10-09 Registered with US (FDA) Canada (Health Canada)	Boston Scientific Corp	2025-10-09	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Pediatric Plating Platform I Small-Mini Orthopediatrics, LLC Cleared 2025-10-09 Registered with US (FDA)	Orthopediatrics, LLC	2025-10-09	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)
SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) Haemoband Surgical, Ltd. Cleared 2025-10-09 Registered with US (FDA)	Haemoband Surgical, Ltd.	2025-10-09	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)
iFuse Bedrock Granite™ Implant System Si-Bone, Inc. Cleared 2025-10-09 Registered with US (FDA)	Si-Bone, Inc.	2025-10-09	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)
Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) Honsun(Nantong) Co., Ltd. Cleared 2025-10-09 Registered with US (FDA)	Honsun(Nantong) Co., Ltd.	2025-10-09	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)
Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S) Clinical Innovations, Inc. Cleared 2025-10-08 Registered with US (FDA)	Clinical Innovations, Inc.	2025-10-08	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)
Elecsys Phospho-Tau (181P) Plasma Roche Diagnostics GmbH Cleared 2025-10-08 Registered with US (FDA)	Roche Diagnostics GmbH	2025-10-08	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)
ProKnow DS Elekta Solutions AB Cleared 2025-10-08 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Elekta Solutions AB	2025-10-08	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
14Fr Low Profile Introducer Kit Abiomed, Inc. Cleared 2025-10-08 Registered with US (FDA)	Abiomed, Inc.	2025-10-08	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)
Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 Serpex Medical, Inc. Cleared 2025-10-08 Registered with US (FDA)	Serpex Medical, Inc.	2025-10-08	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)
GT300; GT300-C Genoray Co., Ltd. Cleared 2025-10-08 Registered with US (FDA)	Genoray Co., Ltd.	2025-10-08	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)
CUSA Clarity Ultrasonic Surgical Aspirator System Integra Lifesciences Corp. Cleared 2025-10-08 Registered with US (FDA)	Integra Lifesciences Corp.	2025-10-08	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)
The Botticelli (Model: Athena) Bellamia Technologies, Inc. Cleared 2025-10-08 Registered with US (FDA)	Bellamia Technologies, Inc.	2025-10-08	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)
MetaFore Small Screw System Extremity Medical LLC Cleared 2025-10-08 Registered with US (FDA)	Extremity Medical LLC	2025-10-08	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)
BD Saf-T-Intima™ Subcutaneous Catheter System Becton Dickinson Infusion Therapy Systems, Inc. Cleared 2025-10-08 Registered with US (FDA)	Becton Dickinson Infusion Therapy Systems, Inc.	2025-10-08	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)
Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC) Olympus Medical Systems Corporation Cleared 2025-10-07 Registered with US (FDA)	Olympus Medical Systems Corporation	2025-10-07	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)
Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US) Acotec Scientific Co., Ltd. Cleared 2025-10-07 Registered with US (FDA)	Acotec Scientific Co., Ltd.	2025-10-07	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)
AIAS Cephalon Metamorphosis GmbH Cleared 2025-10-07 Registered with US (FDA)	Metamorphosis GmbH	2025-10-07	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)
Eminent Spine Posterior SI System Eminent Spine Cleared 2025-10-07 Registered with US (FDA)	Eminent Spine	2025-10-07	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)
deepLive (OSP12 + DMS) Damae Medical Cleared 2025-10-07 Registered with US (FDA)	Damae Medical	2025-10-07	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)
Prodeon Urethral Sheath System Prodeon Medical, Inc. Cleared 2025-10-07 Registered with US (FDA)	Prodeon Medical, Inc.	2025-10-07	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)
TrueBeam, TrueBeam STx, Edge, VitalBeam Varian Medical Systems inc Cleared 2025-10-07 Registered with US (FDA)	Varian Medical Systems inc	2025-10-07	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 Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) Olympus Medical Systems Corporation Cleared 2025-10-07 Registered with US (FDA)	Olympus Medical Systems Corporation	2025-10-07	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)
Aptima HBV Quant Assay Hologic Inc Cleared 2025-10-07 Registered with US (FDA) AU (TGA)	Hologic Inc	2025-10-07	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Ultrasound Therapy Workstation (XMS-UET2) Xemis Medical Technology (Shenzhen) Co., Ltd. Cleared 2025-10-07 Registered with US (FDA)	Xemis Medical Technology (Shenzhen) Co., Ltd.	2025-10-07	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)
BlineSlide Deep Breathe, Inc. Cleared 2025-10-06 Registered with US (FDA)	Deep Breathe, Inc.	2025-10-06	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™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR) Covidien Cleared 2025-10-06 Registered with US (FDA)	Covidien	2025-10-06	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)
Tigertriever 17 Ultra Revascularization Device Rapid-Medical , Ltd. Cleared 2025-10-06 Registered with US (FDA) AU (TGA)	Rapid-Medical , Ltd.	2025-10-06	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Folding Mobility Scooter (KD101) Nanjing Kangni Smart Technology Co., Ltd. Cleared 2025-10-06 Registered with US (FDA)	Nanjing Kangni Smart Technology Co., Ltd.	2025-10-06	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)
Wheelchair (N817) Zhejiang Topwe Tools Manufacturing Co.,Ltd Cleared 2025-10-06 Registered with US (FDA)	Zhejiang Topwe Tools Manufacturing Co.,Ltd	2025-10-06	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)
Heylo™ System Coloplast Corp. Cleared 2025-10-06 Registered with US (FDA)	Coloplast Corp.	2025-10-06	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)
Capsular Tension Ring (275,276); RingJect (375,376) Ophtec BV Cleared 2025-10-06 Registered with US (FDA)	Ophtec BV	2025-10-06	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)
PainChek (PainChek Adult) Painchek Limited (Ltd.) Cleared 2025-10-06 Registered with US (FDA)	Painchek Limited (Ltd.)	2025-10-06	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)