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
CMORE® CT System; CMORE® CT System Navigated Instruments Icotec Cleared 2025-11-12 Registered with US (FDA)	Icotec	2025-11-12	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)
PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture ETHICON LLC Cleared 2025-11-12 Registered with US (FDA)	ETHICON LLC	2025-11-12	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)
IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) Philips Medizin Systeme Boblingen GmbH Cleared 2025-11-10 Registered with US (FDA)	Philips Medizin Systeme Boblingen GmbH	2025-11-10	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)
Atlas Spine HiRISE™ Expandable Cervical Corpectomy System Atlas Spine, LLC Cleared 2025-11-10 Registered with US (FDA)	Atlas Spine, LLC	2025-11-10	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)
KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE KLS Martin SE & Co KG Cleared 2025-11-10 Registered with US (FDA)	KLS Martin SE & Co KG	2025-11-10	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)
EzSensor HD, EzSensor UHD Qpix Solutions, Inc. Cleared 2025-11-10 Registered with US (FDA)	Qpix Solutions, Inc.	2025-11-10	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)
NeVasc Aspiration System Vesalio Cleared 2025-11-10 Registered with US (FDA)	Vesalio	2025-11-10	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)
Withings BeamO (SCT02) Withings Cleared 2025-11-10 Registered with US (FDA)	Withings	2025-11-10	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)
Symani Surgical System Medical Microinstruments, Inc. Cleared 2025-11-10 Registered with US (FDA)	Medical Microinstruments, Inc.	2025-11-10	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)
Lunderquist Extra Stiff Wire Guide William Cook Europe Aps Cleared 2025-11-09 Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA)	William Cook Europe Aps	2025-11-09	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
MultiMatch Flow Chameleon AntiMicrobial Composite Premier Dental Products Co. Cleared 2025-11-07 Registered with US (FDA)	Premier Dental Products Co.	2025-11-07	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)
Triathlon Pro Sigma Biomedical Cleared 2025-11-07 Registered with US (FDA)	Sigma Biomedical	2025-11-07	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)
Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System Inion OY Cleared 2025-11-07 Registered with US (FDA)	Inion OY	2025-11-07	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)
SugarBug (1.x) Bench7, Inc. Cleared 2025-11-07 Registered with US (FDA)	Bench7, Inc.	2025-11-07	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)
Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS) Intersect Ent. Cleared 2025-11-07 Registered with US (FDA) AU (TGA)	Intersect Ent.	2025-11-07	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
ulrichINJECT CT Motion (XD 8000) Ulrich GmbH & Co. KG Cleared 2025-11-07 Registered with US (FDA)	Ulrich GmbH & Co. KG	2025-11-07	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)
Fibresolve (with PCCP) Imvaria, Inc. Cleared 2025-11-07 Registered with US (FDA)	Imvaria, Inc.	2025-11-07	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)
AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA Topcon Corp. Cleared 2025-11-07 Registered with US (FDA) EU (EUDAMED)	Topcon Corp.	2025-11-07	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
S.I.N. Tapered Pro Conical Zygoma Implant System SIN IMPLANT SYSTEM LTDA Cleared 2025-11-07 Registered with US (FDA)	SIN IMPLANT SYSTEM LTDA	2025-11-07	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)
BRAINSWAY DEEP TMS SYSTEM Brainsway , Ltd. Cleared 2025-11-07 Registered with US (FDA)	Brainsway , Ltd.	2025-11-07	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)
Electric Wheelchair (Rollz Motion Electric 2M) Rollz International BV Cleared 2025-11-07 Registered with US (FDA)	Rollz International BV	2025-11-07	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)
Medical Diode Laser Systems (VeinCure) Baoding Te'Anzhou Electronic Technology Co., Ltd. Cleared 2025-11-07 Registered with US (FDA)	Baoding Te'Anzhou Electronic Technology Co., Ltd.	2025-11-07	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)
Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Cleared 2025-11-07 Registered with US (FDA)	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2025-11-07	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)
Primeprint Direct Aligner Dreve Dentamid GmbH Cleared 2025-11-07 Registered with US (FDA) Canada (Health Canada)	Dreve Dentamid GmbH	2025-11-07	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
CO2 Laser Therapy System (K106) Hebei Keylaser Sci-Tech Co.,Ltd Cleared 2025-11-07 Registered with US (FDA)	Hebei Keylaser Sci-Tech Co.,Ltd	2025-11-07	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)
Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) Hefei Chimed Intelligent Machine Co., Ltd. Cleared 2025-11-06 Registered with US (FDA)	Hefei Chimed Intelligent Machine Co., Ltd.	2025-11-06	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)
MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA DMP Dental Industry SA Cleared 2025-11-06 Registered with US (FDA)	DMP Dental Industry SA	2025-11-06	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)
Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant Stryker Leibinger Cleared 2025-11-06 Registered with US (FDA) AU (TGA)	Stryker Leibinger	2025-11-06	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Catalyst F1x Shoulder System Catalyst Orthoscience, LLC Cleared 2025-11-06 Registered with US (FDA)	Catalyst Orthoscience, LLC	2025-11-06	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)
Motive™ Muscle Stimulator for Lower Back (OT01-1003) Motive Health, Inc. Cleared 2025-11-06 Registered with US (FDA)	Motive Health, Inc.	2025-11-06	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)
Venus Nova (FP-2001) Venus Concept , Ltd. Cleared 2025-11-06 Registered with US (FDA)	Venus Concept , Ltd.	2025-11-06	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)
LIFEPAK® CR2 Defibrillator Physio-Control, Inc. Cleared 2025-11-06 Registered with US (FDA) Canada (Health Canada)	Physio-Control, Inc.	2025-11-06	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Ultra™ Compression Screw System Pace Surgical Cleared 2025-11-06 Registered with US (FDA)	Pace Surgical	2025-11-06	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)
mb-FIX Cranial Stabilization Systems Medical Bees GmbH Cleared 2025-11-06 Registered with US (FDA)	Medical Bees GmbH	2025-11-06	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)
Tandem Mobi Insulin Pump with Interoperable Technology Tandem Diabetes Care, Inc. Cleared 2025-11-06 Registered with US (FDA)	Tandem Diabetes Care, Inc.	2025-11-06	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)
Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) Stereotaxis, Inc. Cleared 2025-11-06 Registered with US (FDA)	Stereotaxis, Inc.	2025-11-06	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)
Q-Switched Nd:Yag laser (K690) Hebei Keylaser Sci-Tech Co.,Ltd Cleared 2025-11-06 Registered with US (FDA)	Hebei Keylaser Sci-Tech Co.,Ltd	2025-11-06	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)
Adaptix Ortho350 Adaptix Limited Cleared 2025-11-06 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Adaptix Limited	2025-11-06	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Hubly Drill (H100) Hubly, Inc. Cleared 2025-11-06 Registered with US (FDA)	Hubly, Inc.	2025-11-06	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)
AIO Breathe Aiomega, LLC Cleared 2025-11-06 Registered with US (FDA)	Aiomega, LLC	2025-11-06	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)
Polyshield Safety IV Catheters Poly Medicure Limited Cleared 2025-11-05 Registered with US (FDA)	Poly Medicure Limited	2025-11-05	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)
ViVY Viatherm Therapeutics, LLC Cleared 2025-11-05 Registered with US (FDA)	Viatherm Therapeutics, LLC	2025-11-05	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)
OncoMate® MSI Dx Analysis System Promega Corporation Cleared 2025-11-05 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Promega Corporation	2025-11-05	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
ExcelsiusGPS® Instruments Globus Medical, Inc. Cleared 2025-11-05 Registered with US (FDA)	Globus Medical, Inc.	2025-11-05	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)
Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept Beijing Sinovation Medical Technology Co., Ltd. Cleared 2025-11-05 Registered with US (FDA)	Beijing Sinovation Medical Technology Co., Ltd.	2025-11-05	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)
EVAC-MRI Phasor Health, LLC Cleared 2025-11-05 Registered with US (FDA)	Phasor Health, LLC	2025-11-05	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)
Allure Hip Stem and Intramedullary Plugs Waldemar Link GmbH & Co. KG Cleared 2025-11-05 Registered with US (FDA)	Waldemar Link GmbH & Co. KG	2025-11-05	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)
Voyant® Open Fusion Device (EB240/Open Fusion) Applied Medical Resources Cleared 2025-11-04 Registered with US (FDA)	Applied Medical Resources	2025-11-04	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)
Tamburo Thulium Fiber Laser System Menovex Medical Technology (Shenzhen) Co., Ltd. Cleared 2025-11-04 Registered with US (FDA)	Menovex Medical Technology (Shenzhen) Co., Ltd.	2025-11-04	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)
Flexx Junior (FLX-J00, FLX-J50) Karma Mobility Ltd Cleared 2025-11-04 Registered with US (FDA)	Karma Mobility Ltd	2025-11-04	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)