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.

3,665 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
Vortex5 Tailor's Bunion Correction System Nvision Biomedical Technologies, LLC Cleared 2026-03-25 Registered with US (FDA)	Nvision Biomedical Technologies, LLC	2026-03-25	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)
Flex-Z™ Cervical Cage Spinepoint, LLC Cleared 2026-03-25 Registered with US (FDA)	Spinepoint, LLC	2026-03-25	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)
Airlock® Ankle Plating System Novastep SAS Cleared 2026-03-25 Registered with US (FDA)	Novastep SAS	2026-03-25	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)
LYNX COBLATION Laryngeal Wand (72290254) Arthrocare Corp. Cleared 2026-03-25 Registered with US (FDA)	Arthrocare Corp.	2026-03-25	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)
Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) Zhuhai Wesee Meditech Co., Ltd. Cleared 2026-03-25 Registered with US (FDA)	Zhuhai Wesee Meditech Co., Ltd.	2026-03-25	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)
CUVIS-joint (CJ150) CUREXO, INC. Cleared 2026-03-25 Registered with US (FDA)	CUREXO, INC.	2026-03-25	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)
Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle Sandstone Medical (Suzhou), Inc. Cleared 2026-03-25 Registered with US (FDA)	Sandstone Medical (Suzhou), Inc.	2026-03-25	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)
Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78" Infant Circuit, HUD99060KIT / Dri-Tech with 78" Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60" Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44" Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel) Medline Industries, Inc. Cleared 2026-03-25 Registered with US (FDA)	Medline Industries, Inc.	2026-03-25	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)
Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) Bausch & Lomb Incorporated Cleared 2026-03-25 Registered with US (FDA)	Bausch & Lomb Incorporated	2026-03-25	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)
PRESSONE™ NIPRO MEDICAL CORPORATION Cleared 2026-03-24 Registered with US (FDA)	NIPRO MEDICAL CORPORATION	2026-03-24	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)
Electric Wheelchair (E201) Nanjing CareMoving Rehabilitation Equipment Co, Ltd Cleared 2026-03-24 Registered with US (FDA)	Nanjing CareMoving Rehabilitation Equipment Co, Ltd	2026-03-24	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)
Barricaid Anular Closure Device Intrinsic Therapeutics Incorporated Cleared 2026-03-24 Registered with US (FDA)	Intrinsic Therapeutics Incorporated	2026-03-24	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)
NanoKnife Generator (H78720300351US0) AngioDynamics, Inc. Cleared 2026-03-24 Registered with US (FDA)	AngioDynamics, Inc.	2026-03-24	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)
Access BNP II Beckman Coulter, Inc. Cleared 2026-03-24 Registered with US (FDA) Canada (Health Canada) EU (EUDAMED)	Beckman Coulter, Inc.	2026-03-24	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Cleared 2026-03-24 Registered with US (FDA)	GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC	2026-03-24	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)
JLK-NCCT JLK, Inc. Cleared 2026-03-24 Registered with US (FDA)	JLK, Inc.	2026-03-24	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)
Trinias Shimadzu Corp. Cleared 2026-03-24 Registered with US (FDA) Canada (Health Canada) EU (EUDAMED)	Shimadzu Corp.	2026-03-24	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
LOQTEQ® VA Proximal Humerus Plate 3.5 aap Implantate AG Cleared 2026-03-24 Registered with US (FDA)	aap Implantate AG	2026-03-24	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)
FebriDx Bacterial/Non-bacterial Assay LUMOS DIAGNOSTICS INCORPORATED Cleared 2026-03-24 Registered with US (FDA)	LUMOS DIAGNOSTICS INCORPORATED	2026-03-24	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)
Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright Ge Medical Systems Scs Cleared 2026-03-24 Registered with US (FDA)	Ge Medical Systems Scs	2026-03-24	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)
Exablate Model 4000 Type 1.0 and 1.1 ("Exablate Neuro"; "Exablate Prime") Insightec, Inc. Cleared 2026-03-23 Registered with US (FDA)	Insightec, Inc.	2026-03-23	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)
Clavicle Fixation System Skeletal Dynamics, LLC Cleared 2026-03-23 Registered with US (FDA)	Skeletal Dynamics, LLC	2026-03-23	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)
MOBI-C CERVICAL DISC PROSTHESIS Highridge Medical LLC Cleared 2026-03-23 Registered with US (FDA)	Highridge Medical LLC	2026-03-23	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)
LED Light Therapy Masks (LumiLips FAC07NA) GUANGDONG NEWDERMO BIOTECH CO., LTD Cleared 2026-03-23 Registered with US (FDA)	GUANGDONG NEWDERMO BIOTECH CO., LTD	2026-03-23	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)
Adin Long Dental Implant System Adin Dental Implant Systems Ltd Cleared 2026-03-23 Registered with US (FDA)	Adin Dental Implant Systems Ltd	2026-03-23	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)
QuikFix External Fixator: Knee-Spanning Pack Stabiliz Orthopaedics, LLC Cleared 2026-03-23 Registered with US (FDA)	Stabiliz Orthopaedics, LLC	2026-03-23	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 Definition DL Ge Healthcare Japan Corporation Cleared 2026-03-23 Registered with US (FDA)	Ge Healthcare Japan Corporation	2026-03-23	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)
HyperSuture All Green Extension Line Threadstone, LLC Cleared 2026-03-23 Registered with US (FDA)	Threadstone, LLC	2026-03-23	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)
LDR Spine Mobi-C Cervical Disc Prosthesis (Two Level) Highridge Medical LLC Cleared 2026-03-23 Registered with US (FDA)	Highridge Medical LLC	2026-03-23	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)
CT Rembra RT; CT Areta RT; CT Rembra Philips Healthcare (Suzhou) Co., Ltd. Cleared 2026-03-23 Registered with US (FDA)	Philips Healthcare (Suzhou) Co., Ltd.	2026-03-23	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)
MDx-Chex for BCN Streck Cleared 2026-03-23 Registered with US (FDA)	Streck	2026-03-23	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)
SUPERA PERIPHERAL STENT SYSTEM Abbott Vascular (Idef Technologies Inc) Cleared 2026-03-20 Registered with US (FDA)	Abbott Vascular (Idef Technologies Inc)	2026-03-20	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)
XACT CAROTID STENT SYSTEM Abbott Vascular, Inc. Cleared 2026-03-20 Registered with US (FDA)	Abbott Vascular, Inc.	2026-03-20	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 Humeral Nails Arthrex, Inc. Cleared 2026-03-20 Registered with US (FDA)	Arthrex, Inc.	2026-03-20	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)
ClaveQS™ Bag ICU Medical, Inc Cleared 2026-03-20 Registered with US (FDA)	ICU Medical, Inc	2026-03-20	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)
Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S) Hangzhou Tappa Medical Technology Co, Ltd Cleared 2026-03-20 Registered with US (FDA)	Hangzhou Tappa Medical Technology Co, Ltd	2026-03-20	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)
Percutaneous Endoscopic Gastrostomy (PEG) Kit Degania Silicone , Ltd. Cleared 2026-03-20 Registered with US (FDA)	Degania Silicone , Ltd.	2026-03-20	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 Fit TorsoCardiac 1.5T Philips Healthcare (Suzhou) Co., Ltd. Cleared 2026-03-20 Registered with US (FDA) Canada (Health Canada) EU (EUDAMED)	Philips Healthcare (Suzhou) Co., Ltd.	2026-03-20	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Livi Device Liviwell, Inc. Cleared 2026-03-20 Registered with US (FDA)	Liviwell, Inc.	2026-03-20	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)
Noxturnal Web Nox Medical Ehf Cleared 2026-03-20 Registered with US (FDA)	Nox Medical Ehf	2026-03-20	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)
FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 Fmd, LLC Cleared 2026-03-20 Registered with US (FDA)	Fmd, LLC	2026-03-20	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)
NOMAD Pro 3 Dental Imaging Technologies Corporation Cleared 2026-03-20 Registered with US (FDA)	Dental Imaging Technologies Corporation	2026-03-20	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)
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) Nexstim Plc Cleared 2026-03-20 Registered with US (FDA)	Nexstim Plc	2026-03-20	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)
nordicAudio (1.0) Nordicneurolab Cleared 2026-03-20 Registered with US (FDA)	Nordicneurolab	2026-03-20	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 (JJW-7002, JJW-7003) ZheJiang J&J Mobility Co., Ltd. Cleared 2026-03-20 Registered with US (FDA)	ZheJiang J&J Mobility Co., Ltd.	2026-03-20	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)
Valvuloplasty Balloon Catheter (ValvuloPro) Dongguan TT Medical, Inc. Cleared 2026-03-20 Registered with US (FDA)	Dongguan TT Medical, Inc.	2026-03-20	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)
HemosIL Factor V Leiden (APC Resistance V) Instrumentation Laboratory (IL) Co. Cleared 2026-03-20 Registered with US (FDA)	Instrumentation Laboratory (IL) Co.	2026-03-20	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)
TiLink-L Navigation Instruments SurGenTec, LLC Cleared 2026-03-20 Registered with US (FDA)	SurGenTec, LLC	2026-03-20	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)
SOMATOM X.cite; SOMATOM X.ceed Siemens Medical Solutions USA, Inc. Cleared 2026-03-20 Registered with US (FDA)	Siemens Medical Solutions USA, Inc.	2026-03-20	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 FIBERTAK SUTURE ANCHOR Arthrex, Inc. Cleared 2026-03-20 Registered with US (FDA)	Arthrex, Inc.	2026-03-20	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)