Search FDA 510(k) Devices

5,413 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
721–744 of 3,225
Cleared Oct 10, 2025
HexaPLUS S OneDrill Implant System
K243078 · DZE
Osseofuse International, Inc.
Dental · 375d
Cleared Oct 09, 2025
iFuse Bedrock Granite Implant System
K253094 · OUR
SI-BONE, Inc.
Orthopedic · 16d
Cleared Oct 09, 2025
COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS
K252939 · HEB
Cotton High Tech S.L.
Obstetrics & Gynecology · 24d
Cleared Oct 09, 2025
Lux HD 2530 detector (Lux HD 2530)
K252911 · MQB
Iray Imaging Technology (Haining)...
Radiology · 27d
Cleared Oct 09, 2025
Orca Air/Water and Suction Valves
K252910 · ODC
Boston Scientific
Gastroenterology & Urology · 27d
Cleared Oct 09, 2025
Invisalign Specifix Attachment System
K252870 · NXC
Align Technology, Inc.
Dental · 30d
Cleared Oct 09, 2025
VINScreen Urine Drug Test Cup
K252867 · NFT
Advin Biotech, Inc.
Toxicology · 30d
Cleared Oct 09, 2025
Pediatric Plating Platform I Small-Mini
K252600 · HRS
OrthoPediatrics Corp.
Orthopedic · 52d
Cleared Oct 09, 2025
Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004,...
K252553 · NFO
Shenzhen Jianchao Intelligent...
Neurology · 57d
Cleared Oct 09, 2025
ORA Method LED Gua Sha (GS-04)
K252272 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 79d
Cleared Oct 09, 2025
cleadew GP hydra one
K251876 · MRC
Ophtecs Corporation
Ophthalmic · 113d
Cleared Oct 09, 2025
DIASAFEplusUS (F00013010)
K251851 · FIP
Fresenius Medical Care Renal...
Gastroenterology & Urology · 115d
Cleared Oct 09, 2025
Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)
K251795 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 119d
Cleared Oct 09, 2025
EPIQ Series Diagnostic Ultrasound System
K251651 · IYN
Philips Ultrasound, LLC
Radiology · 133d
Cleared Oct 09, 2025
EEG-1260A Neurofax System (EEG-1260A)
K251366 · OLT
Nihon Kohden Corporation
Neurology · 161d
Cleared Oct 09, 2025
SleeveLUX 24 Anoscope/Proctoscope (P2001)
K250645 · FER
Haemoband Surgical, Ltd.
Gastroenterology & Urology · 219d
Cleared Oct 08, 2025
Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01
K252874 · KTI
Serpex Medical, Inc.
Anesthesiology · 28d
Cleared Oct 08, 2025
14Fr Low Profile Introducer Kit
K252766 · DYB
Abiomed, Inc.
Cardiovascular · 40d
Cleared Oct 08, 2025
Elecsys Phospho-Tau (181P) Plasma
K252163 · SET
Roche Diagnostics
Immunology · 90d
Cleared Oct 08, 2025
The Botticelli (Model: Athena)
K251699 · GEX
Bellamia Technologies, Inc.
General & Plastic Surgery · 128d
Cleared Oct 08, 2025
BD Saf-T-Intima™ Subcutaneous Catheter System
K251422 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 154d
Cleared Oct 08, 2025
ProKnow DS
K251363 · LLZ
Elekta Solutions AB
Radiology · 160d
Cleared Oct 08, 2025
CUSA® Clarity Ultrasonic Surgical Aspirator System
K251162 · LFL
Integra LifeSciences Corporation
General & Plastic Surgery · 176d
Cleared Oct 08, 2025
MetaFore Small Screw System
K250536 · HWC
Extremity Medical, LLC
Orthopedic · 226d