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.

3,664 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
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 (CTR) and RingJect 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)
PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) Internacional Farmaceutica, S.A. DE C.V. Cleared 2025-10-03 Registered with US (FDA)	Internacional Farmaceutica, S.A. DE C.V.	2025-10-03	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)
Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.) Shanghai AnQing Medical Instrument Co., Ltd. Cleared 2025-10-03 Registered with US (FDA)	Shanghai AnQing Medical Instrument Co., Ltd.	2025-10-03	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)
HPACS Healthhub Cleared 2025-10-03 Registered with US (FDA)	Healthhub	2025-10-03	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)
TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) Jeisys Medical, Inc. Cleared 2025-10-03 Registered with US (FDA)	Jeisys Medical, Inc.	2025-10-03	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)
ProSense™ System ICECURE MEDICAL LTD. Cleared 2025-10-03 Registered with US (FDA)	ICECURE MEDICAL LTD.	2025-10-03	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)
AETOS Shoulder System Stemless Humeral Prosthesis Smith & Nephew, Inc. Cleared 2025-10-03 Registered with US (FDA)	Smith & Nephew, Inc.	2025-10-03	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)
Anti Snore Mouthpiece Dongguan Yiyao Science & Technology Development Co., Ltd Cleared 2025-10-03 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Dongguan Yiyao Science & Technology Development Co., Ltd	2025-10-03	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
HESTIA (L200-A) Senbitec Co., Ltd. Cleared 2025-10-03 Registered with US (FDA)	Senbitec Co., Ltd.	2025-10-03	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)
extriCARE® 1000 Negative Pressure Wound Therapy System Alleva Medical Devices Cleared 2025-10-03 Registered with US (FDA)	Alleva Medical Devices	2025-10-03	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)
Bunkerhill MAC Bunkerhill Health Cleared 2025-10-03 Registered with US (FDA)	Bunkerhill Health	2025-10-03	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)
Amplatzer Guidewire Abbott Medical Cleared 2025-10-03 Registered with US (FDA) Canada (Health Canada) AU (TGA)	Abbott Medical	2025-10-03	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A) Hollister, Inc. Cleared 2025-10-03 Registered with US (FDA)	Hollister, Inc.	2025-10-03	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)
Revolve Surgical System Revolve Surgical, Inc. Cleared 2025-10-03 Registered with US (FDA)	Revolve Surgical, Inc.	2025-10-03	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)
Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 Tosoh Bioscience, Inc. Cleared 2025-10-03 Registered with US (FDA)	Tosoh Bioscience, Inc.	2025-10-03	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)
Manual Wheelchair (SYIV100A008) Ningbo Shenyu Medical Equipment Co, Ltd Cleared 2025-10-03 Registered with US (FDA)	Ningbo Shenyu Medical Equipment Co, Ltd	2025-10-03	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)
4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) Shenzhen Sophway Technology Co.,Ltd. Cleared 2025-10-02 Registered with US (FDA)	Shenzhen Sophway Technology Co.,Ltd.	2025-10-02	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)