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
Tina-quant Cardiac high sensitivity CRP III Roche Diagnostics GmbH Cleared 2026-04-02 Registered with US (FDA)	Roche Diagnostics GmbH	2026-04-02	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)
Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) Medical Brands Laboratories B.V. Cleared 2026-04-02 Registered with US (FDA)	Medical Brands Laboratories B.V.	2026-04-02	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)
SPECCHIO EL.EN. S.P.A. Cleared 2026-04-02 Registered with US (FDA)	EL.EN. S.P.A.	2026-04-02	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)
Onclarity™ Self-Collection Kit Becton Dickinson and Company Cleared 2026-04-02 Registered with US (FDA)	Becton Dickinson and Company	2026-04-02	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)
Leforte MMF System JEIL MEDICAL CORPORATION Cleared 2026-04-02 Registered with US (FDA)	JEIL MEDICAL CORPORATION	2026-04-02	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)
BD Insyte™ IV Catheter Becton Dickinson Infusion Therapy Systems, Inc. Cleared 2026-04-02 Registered with US (FDA) UK (MHRA)	Becton Dickinson Infusion Therapy Systems, Inc.	2026-04-02	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women ConvaTec Limited Cleared 2026-04-01 Registered with US (FDA)	ConvaTec Limited	2026-04-01	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)
RM Electrode (RMH 25-01) Retmap, Inc. Cleared 2026-04-01 Registered with US (FDA)	Retmap, Inc.	2026-04-01	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)
Synchrony Stereotaxis, Inc. Cleared 2026-04-01 Registered with US (FDA) EU (EUDAMED)	Stereotaxis, Inc.	2026-04-01	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
SpineSeal Spine Sealant Pramand, LLC Cleared 2026-04-01 Registered with US (FDA)	Pramand, LLC	2026-04-01	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)
Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL) Shenzhen HanHan Technology Co., Ltd. Cleared 2026-04-01 Registered with US (FDA)	Shenzhen HanHan Technology Co., Ltd.	2026-04-01	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)
MOD-C Orthomod, LLC Cleared 2026-04-01 Registered with US (FDA)	Orthomod, LLC	2026-04-01	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)
Impella RP System, Impella RP with Smart Assist System, Impella RP Flex System Abiomed, Inc. Cleared 2026-04-01 Registered with US (FDA)	Abiomed, Inc.	2026-04-01	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)
enHAnce PEEK Bunion System Nvision Biomedical Technologies, LLC Cleared 2026-04-01 Registered with US (FDA)	Nvision Biomedical Technologies, LLC	2026-04-01	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)
Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm) Poly Medicure Limited Cleared 2026-04-01 Registered with US (FDA)	Poly Medicure Limited	2026-04-01	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)
Medical Imaging Calibration Feature (MICF) Apple, Inc. Cleared 2026-04-01 Registered with US (FDA)	Apple, Inc.	2026-04-01	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)
CoLumbo C-Spine Smart Soft Healthcare AD Cleared 2026-04-01 Registered with US (FDA)	Smart Soft Healthcare AD	2026-04-01	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)
DIAM™ Spinal Stabilization System Companion Spine France SAS Cleared 2026-04-01 Registered with US (FDA)	Companion Spine France SAS	2026-04-01	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)
Prana System Prana Surgical Cleared 2026-04-01 Registered with US (FDA)	Prana Surgical	2026-04-01	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)
Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) Hudi Pharma Srl Cleared 2026-04-01 Registered with US (FDA)	Hudi Pharma Srl	2026-04-01	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)
GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only Shenzhen RF Tech Co., Ltd. Cleared 2026-04-01 Registered with US (FDA)	Shenzhen RF Tech Co., Ltd.	2026-04-01	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)
Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro Shenzhen Aoj Medical Technology Co., Ltd. Cleared 2026-04-01 Registered with US (FDA)	Shenzhen Aoj Medical Technology Co., Ltd.	2026-04-01	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)
CraniSeal Dural Sealant Pramand, LLC Cleared 2026-04-01 Registered with US (FDA)	Pramand, LLC	2026-04-01	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)
Safety lancet (XXXVII) Tianjin Huahong Technology Co, Ltd Cleared 2026-03-31 Registered with US (FDA)	Tianjin Huahong Technology Co, Ltd	2026-03-31	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)
Nd: YAG Laser Therapy Systems Sanhe Meditech Co.,Ltd Cleared 2026-03-31 Registered with US (FDA)	Sanhe Meditech Co.,Ltd	2026-03-31	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)
Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) Vatech Co., Ltd. Cleared 2026-03-31 Registered with US (FDA)	Vatech Co., Ltd.	2026-03-31	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)
K5 wheelchair (16" with swing-away footrest 18" with swing-away footrest 20" with swing-away footrest 16" with elevated foot rest(ELR) 18" with elevated foot rest(ELR) 20" with elevated foot rest(ELR)) Zhenjiang Assure Medical Equipment Co., Ltd. Cleared 2026-03-31 Registered with US (FDA)	Zhenjiang Assure Medical Equipment Co., Ltd.	2026-03-31	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)
RW-1 Mediott, Inc. Cleared 2026-03-31 Registered with US (FDA)	Mediott, Inc.	2026-03-31	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)
InjecSURE Injection System Carbon Medical Technologies, Inc. Cleared 2026-03-31 Registered with US (FDA)	Carbon Medical Technologies, Inc.	2026-03-31	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)
FINDER Flu A&B/SARS-CoV-2 Test Baebies, Inc. Cleared 2026-03-30 Registered with US (FDA)	Baebies, Inc.	2026-03-30	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)
Avatar Medical Vision Avatar Medical Cleared 2026-03-30 Registered with US (FDA) EU (EUDAMED)	Avatar Medical	2026-03-30	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
implantcast Packaging System Update Implantcast GmbH Cleared 2026-03-30 Registered with US (FDA)	Implantcast GmbH	2026-03-30	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)
Francisella tularensis Real-time PCR assay Centers For Disease Control and Prevention Cleared 2026-03-30 Registered with US (FDA)	Centers For Disease Control and Prevention	2026-03-30	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)
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Bloomden Bioceramics (Hunan) Co., Ltd. Cleared 2026-03-30 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Bloomden Bioceramics (Hunan) Co., Ltd.	2026-03-30	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System Spectrum Spine, LLC Cleared 2026-03-30 Registered with US (FDA)	Spectrum Spine, LLC	2026-03-30	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)
IntelliVue Measurement Rack 6000 (867317) Philips Medizin Systeme Boblingen GmbH Cleared 2026-03-30 Registered with US (FDA)	Philips Medizin Systeme Boblingen GmbH	2026-03-30	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)
Sagami Original 002 Polyurethane Male Condom MAYER LABORATORIES INC. Cleared 2026-03-30 Registered with US (FDA)	MAYER LABORATORIES INC.	2026-03-30	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)
FLOW FLEXTEND Wand (72290039) Arthrocare Corp. Cleared 2026-03-30 Registered with US (FDA)	Arthrocare Corp.	2026-03-30	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)
AiORTA - Plan v2.0 ViTAA Medical Solutions, Inc. Cleared 2026-03-30 Registered with US (FDA)	ViTAA Medical Solutions, Inc.	2026-03-30	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)
CO2 Laser System Sanhe Meditech Co.,Ltd Cleared 2026-03-28 Registered with US (FDA)	Sanhe Meditech Co.,Ltd	2026-03-28	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)
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) Anumana, Inc. Cleared 2026-03-28 Registered with US (FDA)	Anumana, Inc.	2026-03-28	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)
ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013) ANEUVO Cleared 2026-03-27 Registered with US (FDA)	ANEUVO	2026-03-27	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)
EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Cleared 2026-03-27 Registered with US (FDA)	Samsung Medison Co., Ltd.	2026-03-27	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)
GPA (hexafocon A) Rigid Gas Permeable Contact Lenses Zhuhai Fitlens Medical Technology Co Ltd Cleared 2026-03-27 Registered with US (FDA)	Zhuhai Fitlens Medical Technology Co Ltd	2026-03-27	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)
Asurys Fluid Management System Boston Scientific Corp Cleared 2026-03-27 Registered with US (FDA) Canada (Health Canada)	Boston Scientific Corp	2026-03-27	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
VyPlate Anterior Cervical Plate System Vy Spine, LLC Cleared 2026-03-27 Registered with US (FDA)	Vy Spine, LLC	2026-03-27	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)
SYMPHONY Navigation Ready Instruments MEDOS INTERNATIONAL SARL Cleared 2026-03-27 Registered with US (FDA)	MEDOS INTERNATIONAL SARL	2026-03-27	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)
Electrically Powered Wheelchair (Model YC-01) Yurob Rehabilitation Medical Co, Ltd Cleared 2026-03-27 Registered with US (FDA)	Yurob Rehabilitation Medical Co, Ltd	2026-03-27	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)
Synergy Disc Instruments Synergy Spine Solutions Inc Cleared 2026-03-27 Registered with US (FDA)	Synergy Spine Solutions Inc	2026-03-27	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)
Contour ProtégéAI+ Mim Software, Inc. Cleared 2026-03-27 Registered with US (FDA)	Mim Software, Inc.	2026-03-27	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)