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
PreOp v3 Clouds of Care Cleared 2026-02-13 Registered with US (FDA)	Clouds of Care	2026-02-13	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)
MISAGO® RX Self-expanding Peripheral Stent Terumo Medical Corp. Cleared 2026-02-13 Registered with US (FDA)	Terumo Medical Corp.	2026-02-13	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)
Babyleo TN500 Dragerwerk AG & Co KGaA Cleared 2026-02-13 Registered with US (FDA) UK (MHRA) AU (TGA) EU (EUDAMED)	Dragerwerk AG & Co KGaA	2026-02-13	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
Armada™ 14 NC PTA Catheter Abbott Medical Cleared 2026-02-13 Registered with US (FDA) EU (EUDAMED)	Abbott Medical	2026-02-13	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Wearable Breast Pump (Model W2) SHENZHEN TPH TECHNOLOGY CO., LTD. Cleared 2026-02-13 Registered with US (FDA)	SHENZHEN TPH TECHNOLOGY CO., LTD.	2026-02-13	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)
VELO Respiratory Test Lex Diagnostics Limited Cleared 2026-02-13 Registered with US (FDA)	Lex Diagnostics Limited	2026-02-13	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 Light CL-100 Contour Research, LLC Cleared 2026-02-13 Registered with US (FDA)	Contour Research, LLC	2026-02-13	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)
Willow 18 Guidewire Arbor Endovascular, LLC Cleared 2026-02-13 Registered with US (FDA)	Arbor Endovascular, LLC	2026-02-13	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)
Endomina EZFuse system Endo Tools Therapeutics SA Cleared 2026-02-13 Registered with US (FDA)	Endo Tools Therapeutics SA	2026-02-13	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)
Chartis Precision Catheter Pulmonx, Inc. Cleared 2026-02-13 Registered with US (FDA)	Pulmonx, Inc.	2026-02-13	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)
cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) VPIX Medical, Inc. Cleared 2026-02-13 Registered with US (FDA)	VPIX Medical, Inc.	2026-02-13	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)
STAR RF Ablation System Merit Medical Systems, Inc. Cleared 2026-02-13 Registered with US (FDA)	Merit Medical Systems, Inc.	2026-02-13	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)
Hive™ Standalone Cervical System and Hive™ C Interbody System NanoHive Medical, LLC Cleared 2026-02-13 Registered with US (FDA)	NanoHive Medical, LLC	2026-02-13	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)
CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) Medinice S.A. Cleared 2026-02-13 Registered with US (FDA)	Medinice S.A.	2026-02-13	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)
DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal Alcon Laboratories Cleared 2026-02-13 Registered with US (FDA)	Alcon Laboratories	2026-02-13	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-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P) Joytech Healthcare Co. , Ltd. Cleared 2026-02-13 Registered with US (FDA)	Joytech Healthcare Co. , Ltd.	2026-02-13	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)
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) Bayer Medical Care Inc Cleared 2026-02-13 Registered with US (FDA)	Bayer Medical Care Inc	2026-02-13	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)
NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722) Shenzhen Best Electronics Co.,Ltd Cleared 2026-02-13 Registered with US (FDA)	Shenzhen Best Electronics Co.,Ltd	2026-02-13	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)
Wearable Breast Pump (Model W12) SHENZHEN TPH TECHNOLOGY CO., LTD. Cleared 2026-02-13 Registered with US (FDA)	SHENZHEN TPH TECHNOLOGY CO., LTD.	2026-02-13	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)
PreemptiveAI Clinical SDK Measure Labs, Inc. (Dba Preemptiveai, Inc.) Cleared 2026-02-13 Registered with US (FDA)	Measure Labs, Inc. (Dba Preemptiveai, Inc.)	2026-02-13	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 Blood Pressure Monitor (BPM-W1VL) Shenzhen IMDK Medical Technology Co, Ltd Cleared 2026-02-13 Registered with US (FDA)	Shenzhen IMDK Medical Technology Co, Ltd	2026-02-13	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)
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) Shanghai United Imaging Healthcare Co., Ltd. Cleared 2026-02-13 Registered with US (FDA)	Shanghai United Imaging Healthcare Co., Ltd.	2026-02-13	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)
Wearable Ambulatory Blood Pressure Monitor (WBP-02A) Shenzhen Hingmed Medical Instrument Co., Ltd. Cleared 2026-02-13 Registered with US (FDA)	Shenzhen Hingmed Medical Instrument Co., Ltd.	2026-02-13	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)
Argos Infinity (Rev. 1.0) Retia Medical Systems Inc Cleared 2026-02-13 Registered with US (FDA)	Retia Medical Systems Inc	2026-02-13	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)
Motion InBra (YM-8801) wearable breast pump Medela, Inc. Cleared 2026-02-13 Registered with US (FDA)	Medela, Inc.	2026-02-13	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)
ARCHITECT Free PSA; Alinity i Free PSA (LN 6C07/07P93) Abbott Laboratories Cleared 2026-02-12 Registered with US (FDA)	Abbott Laboratories	2026-02-12	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)
Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application Medtronic Navigation Inc Cleared 2026-02-12 Registered with US (FDA)	Medtronic Navigation Inc	2026-02-12	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)
Duo Venous Stent System Philips Image Guided Therapy Corporation Cleared 2026-02-12 Registered with US (FDA)	Philips Image Guided Therapy Corporation	2026-02-12	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)
Freestyle Bioprosthesis Medtronic, Inc Cleared 2026-02-12 Registered with US (FDA) UK (MHRA) AU (TGA)	Medtronic, Inc	2026-02-12	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) SZ KKS Silicone&Electronic Co., Ltd. Cleared 2026-02-12 Registered with US (FDA)	SZ KKS Silicone&Electronic Co., Ltd.	2026-02-12	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)
VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump Biosense Webster, Inc. Cleared 2026-02-12 Registered with US (FDA)	Biosense Webster, Inc.	2026-02-12	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)
Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) Guangzhou Hehong Biotech Co., Ltd. Cleared 2026-02-12 Registered with US (FDA)	Guangzhou Hehong Biotech Co., Ltd.	2026-02-12	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)
Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test Healgen Scientific, LLC Cleared 2026-02-12 Registered with US (FDA)	Healgen Scientific, LLC	2026-02-12	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)
Well-Life Incontinence Stimulation System (WL-2405i(P)) Well-Life Healthcare, Inc. Cleared 2026-02-12 Registered with US (FDA)	Well-Life Healthcare, Inc.	2026-02-12	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)
Drug Delivery Infusion Pump Model 8667 Medtronic, Inc Cleared 2026-02-12 Registered with US (FDA)	Medtronic, Inc	2026-02-12	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)
Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions Roche Diagnostics GmbH Cleared 2026-02-12 Registered with US (FDA)	Roche Diagnostics GmbH	2026-02-12	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 Fracture System Met One Technologies Cleared 2026-02-12 Registered with US (FDA)	Met One Technologies	2026-02-12	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)
Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) Tianjin Huahong Technology Co, Ltd Cleared 2026-02-12 Registered with US (FDA)	Tianjin Huahong Technology Co, Ltd	2026-02-12	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)
PuraCath Firefly Needleless Connector IT (9005) Puracath Medical, Inc. Cleared 2026-02-12 Registered with US (FDA)	Puracath Medical, Inc.	2026-02-12	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)
IMAGE1 (TC400US); X-to-4U Adapter (TC040) Karl Storz SE & CO.KG Cleared 2026-02-12 Registered with US (FDA)	Karl Storz SE & CO.KG	2026-02-12	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)
ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions Roche Diagnostics GmbH Cleared 2026-02-12 Registered with US (FDA)	Roche Diagnostics GmbH	2026-02-12	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)
Lumbar Spine Truss System Plating Solution (LSTS-PS) 4Web, Inc. Cleared 2026-02-12 Registered with US (FDA)	4Web, Inc.	2026-02-12	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)
L12 LED Light Source with AIM Stryker Endoscopy Cleared 2026-02-12 Registered with US (FDA)	Stryker Endoscopy	2026-02-12	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)
Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) Xenocor, Inc. Cleared 2026-02-12 Registered with US (FDA)	Xenocor, Inc.	2026-02-12	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)
MINERVA ENDOMETRIAL ABLATION SYSTEM Axora Medical, Inc. Cleared 2026-02-12 Registered with US (FDA)	Axora Medical, Inc.	2026-02-12	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)
AGENT Paclitaxel-Coated Balloon Catheter Boston Scientific Corp Cleared 2026-02-11 Registered with US (FDA)	Boston Scientific Corp	2026-02-11	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)
Optune Pax Novocure, GmbH Cleared 2026-02-11 Registered with US (FDA)	Novocure, GmbH	2026-02-11	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)
SteriHub™ Disinfecting Device and Protective Cover 1World Vista Medical Cleared 2026-02-11 Registered with US (FDA)	1World Vista Medical	2026-02-11	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 INTRA Ti™ Implant System Si-Bone, Inc. Cleared 2026-02-11 Registered with US (FDA)	Si-Bone, Inc.	2026-02-11	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)
AI4CMR v2.0 AI4MedImaging Medical Solutions SA Cleared 2026-02-11 Registered with US (FDA)	AI4MedImaging Medical Solutions SA	2026-02-11	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)