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
Spo2 Sensor CSS032D Shenzhen YKD Technology Co,Ltd Cleared 2025-12-19 Registered with US (FDA)	Shenzhen YKD Technology Co,Ltd	2025-12-19	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)
Pectus Versa System GM Dos Reis Industria e Comercio Ltda. Cleared 2025-12-19 Registered with US (FDA)	GM Dos Reis Industria e Comercio Ltda.	2025-12-19	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 Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) Guangdong Youmeng Electrical Technology Co., Ltd. Cleared 2025-12-19 Registered with US (FDA)	Guangdong Youmeng Electrical Technology Co., Ltd.	2025-12-19	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)
SUPARTZ FX; VISCO-3 Seikagaku Corp. Cleared 2025-12-19 Registered with US (FDA)	Seikagaku Corp.	2025-12-19	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)
ClearCalc Model RADCA V2.6 Radformation Cleared 2025-12-19 Registered with US (FDA)	Radformation	2025-12-19	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)
SANDRO Dual WONTECH CO., LTD. Cleared 2025-12-19 Registered with US (FDA)	WONTECH CO., LTD.	2025-12-19	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 (MJ1L, MJ2L, RN3L, RN4L,RN5L) Ningbo Ranor Medical Science & Technology Co., Ltd. Cleared 2025-12-19 Registered with US (FDA)	Ningbo Ranor Medical Science & Technology Co., Ltd.	2025-12-19	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)
Endura™ Ureteral Stent and Stent Set Cathegenix (Xiamen) Co., Ltd. Cleared 2025-12-19 Registered with US (FDA)	Cathegenix (Xiamen) Co., Ltd.	2025-12-19	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)
EXCOR Pediatric Ventricular Assist Device Berlin Heart, Inc. Cleared 2025-12-19 Registered with US (FDA)	Berlin Heart, Inc.	2025-12-19	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)
SCOUT MD Surgical Guidance System Merit Medical Systems, Inc. Cleared 2025-12-19 Registered with US (FDA)	Merit Medical Systems, Inc.	2025-12-19	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)
Vivo 45 LS Oconnell Regulatory Consultants, Inc. Cleared 2025-12-19 Registered with US (FDA)	Oconnell Regulatory Consultants, Inc.	2025-12-19	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)
Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay Diazyme Laboratories Cleared 2025-12-19 Registered with US (FDA)	Diazyme Laboratories	2025-12-19	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)
eMurmur Heart AI Csd Labs GmbH Cleared 2025-12-19 Registered with US (FDA) EU (EUDAMED)	Csd Labs GmbH	2025-12-19	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
LED Light Therapy Device (Models: SG-FM, SG-FE) SUNGLOR TECHNOLOGY CO., LTD Cleared 2025-12-19 Registered with US (FDA)	SUNGLOR TECHNOLOGY CO., LTD	2025-12-19	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)
Balanced Knee System TriMax Porous Femoral Components Ortho Development Corp. Cleared 2025-12-19 Registered with US (FDA)	Ortho Development Corp.	2025-12-19	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)
DBLG2 DIABELOOP SA Cleared 2025-12-19 Registered with US (FDA)	DIABELOOP SA	2025-12-19	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)
eRapid with eTrack System PARI RESPIRATORY EQUIPMENT, INC. Cleared 2025-12-19 Registered with US (FDA)	PARI RESPIRATORY EQUIPMENT, INC.	2025-12-19	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)
Hoffmann LRF System Stryker Corp. Cleared 2025-12-19 Registered with US (FDA)	Stryker Corp.	2025-12-19	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)
iCEM Universal Plus Kulzer, LLC Cleared 2025-12-19 Registered with US (FDA)	Kulzer, LLC	2025-12-19	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)
LIA-1 Catheter (542-1) Leadoptik, Inc. Cleared 2025-12-19 Registered with US (FDA)	Leadoptik, Inc.	2025-12-19	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)
Monkey Rings External Ring Fixation System Paragon 28, Inc Cleared 2025-12-19 Registered with US (FDA)	Paragon 28, Inc	2025-12-19	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)
PVAD IQ Software Ultrasight, Inc. Cleared 2025-12-18 Registered with US (FDA)	Ultrasight, Inc.	2025-12-18	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)
OTSCneo System Set (100.03n-14n, 100.27n-31n) Ovesco Endoscopy AG Cleared 2025-12-18 Registered with US (FDA)	Ovesco Endoscopy AG	2025-12-18	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)
Assert-IQ (DM5100) Abbott Medical Cleared 2025-12-18 Registered with US (FDA)	Abbott Medical	2025-12-18	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)
MOVIVA® Hybrid Ablation Probe Erbe Elektromedizin GmbH Cleared 2025-12-18 Registered with US (FDA)	Erbe Elektromedizin GmbH	2025-12-18	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)
Amethyst HP PTA OTW 0.035 Catheter NATEC MEDICAL LTD. Cleared 2025-12-18 Registered with US (FDA)	NATEC MEDICAL LTD.	2025-12-18	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)
Dental Cone; Dental Sponge Medizin Produkte Neustadt GmbH (Mpn) Cleared 2025-12-18 Registered with US (FDA)	Medizin Produkte Neustadt GmbH (Mpn)	2025-12-18	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)
Cerene Cryotherapy Device Channel Medsystems, Inc. Cleared 2025-12-18 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	Channel Medsystems, Inc.	2025-12-18	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
RefleXion Medical Radiotherapy System, Reflexion X2 Reflexion Medical, Inc. Cleared 2025-12-18 Registered with US (FDA)	Reflexion Medical, Inc.	2025-12-18	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)
FX CorAL 40; FX CorAL 50 Fresenius Medical Care Renal Therapies Group, LLC Cleared 2025-12-18 Registered with US (FDA)	Fresenius Medical Care Renal Therapies Group, LLC	2025-12-18	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)
Tomey Optical Biometer OA-2000 (OA-2000) Tomey Corp. Cleared 2025-12-18 Registered with US (FDA)	Tomey Corp.	2025-12-18	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)
Park Dental Nylon MAD PARK DENTAL RESEARCH CORP. Cleared 2025-12-18 Registered with US (FDA)	PARK DENTAL RESEARCH CORP.	2025-12-18	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 Cytology Brush V (BC-V600P-3010) Olympus Medical Systems Corporation Cleared 2025-12-18 Registered with US (FDA)	Olympus Medical Systems Corporation	2025-12-18	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)
AED Plus Zoll Medical Corp Cleared 2025-12-18 Registered with US (FDA) UK (MHRA)	Zoll Medical Corp	2025-12-18	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
SIMDA Abutments Simda Co., Ltd. Cleared 2025-12-18 Registered with US (FDA)	Simda Co., Ltd.	2025-12-18	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)
CELT ACD VASCULAR CLOSURE DEVICE Vasorum, Ltd. Cleared 2025-12-18 Registered with US (FDA)	Vasorum, Ltd.	2025-12-18	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)
HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) Edwards Lifesciences, LLC Cleared 2025-12-18 Registered with US (FDA)	Edwards Lifesciences, LLC	2025-12-18	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)
Midline Catheter Terumo Medical Products Hangzhou Co., Ltd. Cleared 2025-12-18 Registered with US (FDA)	Terumo Medical Products Hangzhou Co., Ltd.	2025-12-18	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)
Helo Thrombectomy System Endovascular Engineering Cleared 2025-12-18 Registered with US (FDA)	Endovascular Engineering	2025-12-18	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)
MediAI-BA Crescom Co., Ltd. Cleared 2025-12-18 Registered with US (FDA)	Crescom Co., Ltd.	2025-12-18	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)
Spectranetics Laser Sheath (GlideLight/SLS) Spectranetics (Philips) Cleared 2025-12-18 Registered with US (FDA)	Spectranetics (Philips)	2025-12-18	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)
ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C) Jiangsu Jiyuan Medical Technology Co, Ltd Cleared 2025-12-18 Registered with US (FDA)	Jiangsu Jiyuan Medical Technology Co, Ltd	2025-12-18	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)
Coseal Applicator Tips Baxter Bio Science Cleared 2025-12-18 Registered with US (FDA)	Baxter Bio Science	2025-12-18	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)
BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System Bonebridge AG Cleared 2025-12-17 Registered with US (FDA)	Bonebridge AG	2025-12-17	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 Piccolo™ Delivery System (9-PDS-04F-045) Abbott Medical Cleared 2025-12-17 Registered with US (FDA)	Abbott Medical	2025-12-17	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)
CARBOMEDICS PROSTHETIC HEART VALVE Corcym Srl Cleared 2025-12-17 Registered with US (FDA) AU (TGA)	Corcym Srl	2025-12-17	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) Shenzhen Goodwind Technology Development Co., Ltd. Cleared 2025-12-17 Registered with US (FDA)	Shenzhen Goodwind Technology Development Co., Ltd.	2025-12-17	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)
SURFLO Hybria Closed System Safety IV Catheter Terumo Medical Products Hangzhou Co., Ltd. Cleared 2025-12-17 Registered with US (FDA)	Terumo Medical Products Hangzhou Co., Ltd.	2025-12-17	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)
Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons Unibeauty (Hubei) Technology Co., Ltd. Cleared 2025-12-17 Registered with US (FDA)	Unibeauty (Hubei) Technology Co., Ltd.	2025-12-17	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)
ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T) Ethicon Endo-Surgery, Inc. Cleared 2025-12-17 Registered with US (FDA)	Ethicon Endo-Surgery, Inc.	2025-12-17	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)