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.

3,392 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
Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology Integra Lifesciences Production Corporation Cleared 2025-08-08 Registered with US (FDA)	Integra Lifesciences Production Corporation	2025-08-08	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)
LED Light Therapy Mask (M01, M02, M06, M07, M08, M09) SHENZHEN LIYOUTONG TECHNOLOGY CO., LTD. Cleared 2025-08-07 Registered with US (FDA)	SHENZHEN LIYOUTONG TECHNOLOGY CO., LTD.	2025-08-07	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)
Longboard Revision Hip Stem Signature Orthopaedics Pty Ltd Cleared 2025-08-07 Registered with US (FDA)	Signature Orthopaedics Pty Ltd	2025-08-07	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)
Succession™ AFN System Ortho Solutions UK Ltd Cleared 2025-08-07 Registered with US (FDA)	Ortho Solutions UK Ltd	2025-08-07	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)
LuMon(TM) System Sentec, Inc. Cleared 2025-08-07 Registered with US (FDA)	Sentec, Inc.	2025-08-07	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)
BTL-199 Btl Industries, Ltd. Cleared 2025-08-07 Registered with US (FDA)	Btl Industries, Ltd.	2025-08-07	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)
ANGIO-SEAL VIP Vascular Closure Device Terumo Medical Corp. Cleared 2025-08-07 Registered with US (FDA) AU (TGA)	Terumo Medical Corp.	2025-08-07	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Navigo Workstation 2.3 (FPRMC00039) Uc-Care , Ltd. Cleared 2025-08-07 Registered with US (FDA)	Uc-Care , Ltd.	2025-08-07	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)
GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03) Boston Scientific Neuromodulation Corporation Cleared 2025-08-07 Registered with US (FDA)	Boston Scientific Neuromodulation Corporation	2025-08-07	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)
UNiD™ Spine Analyzer Medicrea International S.A.S. (Medtronic) Cleared 2025-08-07 Registered with US (FDA)	Medicrea International S.A.S. (Medtronic)	2025-08-07	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)
Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762) Integra Lifesciences Production Corporation Cleared 2025-08-06 Registered with US (FDA)	Integra Lifesciences Production Corporation	2025-08-06	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)
Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532) Hangzhou Viction Medical Technology Co.,Ltd Cleared 2025-08-06 Registered with US (FDA)	Hangzhou Viction Medical Technology Co.,Ltd	2025-08-06	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)
InterSpace GV Hip Spacer Tecres SpA Cleared 2025-08-06 Registered with US (FDA)	Tecres SpA	2025-08-06	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)
SteadiSet infusion set Tandem Diabetes Care, Inc. Cleared 2025-08-06 Registered with US (FDA)	Tandem Diabetes Care, Inc.	2025-08-06	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)
Olo EL.EN. S.P.A. Cleared 2025-08-06 Registered with US (FDA)	EL.EN. S.P.A.	2025-08-06	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)
Cardiologs Holter Platform Philips France Commercial Cleared 2025-08-06 Registered with US (FDA) AU (TGA)	Philips France Commercial	2025-08-06	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
AEVUMED PHANTOM Suture Anchors Aevumed, Inc. Cleared 2025-08-06 Registered with US (FDA)	Aevumed, Inc.	2025-08-06	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)
Digital Radiographic Imaging Acquisition Software - DR (RiasDR) Shen Zhen Cambridge-Hit Co., Ltd. Cleared 2025-08-06 Registered with US (FDA)	Shen Zhen Cambridge-Hit Co., Ltd.	2025-08-06	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)
Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532; VC-FLB0514; VC-FLB0523; VC-FLB0532; VC-FLC0514; VC-FLC0523; VC-FLC0532; VC-FLD0514; VC-FLD0523; VC-FLD0532) Hangzhou Viction Medical Technology Co.,Ltd Cleared 2025-08-06 Registered with US (FDA)	Hangzhou Viction Medical Technology Co.,Ltd	2025-08-06	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)
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) Microlife Corp. Cleared 2025-08-06 Registered with US (FDA)	Microlife Corp.	2025-08-06	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)
InVision™ 3T Recharge Operating Suite IMRIS IMAGING, INC. Cleared 2025-08-06 Registered with US (FDA) Canada (Health Canada)	IMRIS IMAGING, INC.	2025-08-06	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Respiree Cardio- Respiratory Monitor System Respiree Pte, Ltd. Cleared 2025-08-05 Registered with US (FDA)	Respiree Pte, Ltd.	2025-08-05	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)
Chemfort Female Luer Lock Adaptor Simplivia Healthcare , Ltd. Cleared 2025-08-05 Registered with US (FDA) UK (MHRA)	Simplivia Healthcare , Ltd.	2025-08-05	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
AltiVate Reverse® Glenoid Encore Medical LP Cleared 2025-08-05 Registered with US (FDA)	Encore Medical LP	2025-08-05	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)
PRADO™ Lumbar Interbody Fusion System Bethesda Medical Devices Cleared 2025-08-05 Registered with US (FDA)	Bethesda Medical Devices	2025-08-05	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)
iPETcertum (v1.0) Claritas Healthtech Pte, Ltd. Cleared 2025-08-05 Registered with US (FDA)	Claritas Healthtech Pte, Ltd.	2025-08-05	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)
trophon2 Nanosonics Limited Cleared 2025-08-05 Registered with US (FDA) Canada (Health Canada) EU (EUDAMED)	Nanosonics Limited	2025-08-05	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
uMR Jupiter Shanghai United Imaging Healthcare Co., Ltd. Cleared 2025-08-05 Registered with US (FDA)	Shanghai United Imaging Healthcare Co., Ltd.	2025-08-05	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)
Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) Spectrum Medical Ltd Cleared 2025-08-04 Registered with US (FDA)	Spectrum Medical Ltd	2025-08-04	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)
IC-8 Apthera Intraocular Lens (IOL) Acu Focus, Inc. Cleared 2025-08-04 Registered with US (FDA)	Acu Focus, Inc.	2025-08-04	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)
Terragene® Bionova® BT20 Biological Indicator Terragene S.A. Cleared 2025-08-04 Registered with US (FDA)	Terragene S.A.	2025-08-04	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)
HnX-P1, HnX-PB H&Abyz Cleared 2025-08-04 Registered with US (FDA)	H&Abyz	2025-08-04	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)
T-SPOT .TB TEST Oxford Immunotec, Ltd. Cleared 2025-08-04 Registered with US (FDA) AU (TGA)	Oxford Immunotec, Ltd.	2025-08-04	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr Andon Health Co, Ltd. Cleared 2025-08-04 Registered with US (FDA)	Andon Health Co, Ltd.	2025-08-04	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)
CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739) Okapi Medical, LLC Dba Resivant Medical Cleared 2025-08-04 Registered with US (FDA)	Okapi Medical, LLC Dba Resivant Medical	2025-08-04	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)
IMMULITE 2000 Systems Total Antibodies to Hepatitis B Core Antigen (Anti-HBc) Siemens Healthcare Diagnostics Products Limited Cleared 2025-08-04 Registered with US (FDA)	Siemens Healthcare Diagnostics Products Limited	2025-08-04	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)
INNOVISION-DXII DK Medical Systems Co., Ltd. Cleared 2025-08-01 Registered with US (FDA)	DK Medical Systems Co., Ltd.	2025-08-01	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)
Deepsight NeedleVue LC1 Ultrasound System Deepsight Technology, Inc. Cleared 2025-08-01 Registered with US (FDA)	Deepsight Technology, Inc.	2025-08-01	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)
RONAVIS – FX (FX-001) AIRS, Inc. Cleared 2025-08-01 Registered with US (FDA)	AIRS, Inc.	2025-08-01	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)
eZSURE™ Empty Fluid Container Epic Medical Pte. , Ltd. Cleared 2025-08-01 Registered with US (FDA)	Epic Medical Pte. , Ltd.	2025-08-01	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)
MINI VP1 (PL67_F); MINI VP1 (PL61_F) AVIZOR SA Cleared 2025-08-01 Registered with US (FDA)	AVIZOR SA	2025-08-01	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)
AK 98 Dialysis Machine (955607) VANTIVE US HEALTHCARE LLC Cleared 2025-08-01 Registered with US (FDA)	VANTIVE US HEALTHCARE LLC	2025-08-01	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)
Sparta Infusion Set for Insulin Deka Research & Development Corp. Cleared 2025-08-01 Registered with US (FDA)	Deka Research & Development Corp.	2025-08-01	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)
NOBILCAM IMPAK Disc Shandong Huge Dental Material Corporation Cleared 2025-08-01 Registered with US (FDA)	Shandong Huge Dental Material Corporation	2025-08-01	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)
Revolution Vibe Ge Medical Systems, Inc. Cleared 2025-08-01 Registered with US (FDA)	Ge Medical Systems, Inc.	2025-08-01	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)
QuickSleeper 5 Dentalhitec Cleared 2025-08-01 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Dentalhitec	2025-08-01	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo AMERICAN MEDICAL ENDOSCOPY, INC. Cleared 2025-08-01 Registered with US (FDA)	AMERICAN MEDICAL ENDOSCOPY, INC.	2025-08-01	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)
Access hsTnI Beckman Coulter, Inc. Cleared 2025-08-01 Registered with US (FDA)	Beckman Coulter, Inc.	2025-08-01	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)
MycoMEIA Aspergillus Assay Pearl Diagnostics, Inc. Cleared 2025-08-01 Registered with US (FDA) UK (MHRA)	Pearl Diagnostics, Inc.	2025-08-01	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
AngioJet Thrombectomy System Boston Scientific Corp Cleared 2025-08-01 Registered with US (FDA)	Boston Scientific Corp	2025-08-01	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)