Search FDA 510(k) Devices

5,436 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
1441–1464 of 174,061
Cleared Oct 10, 2025
Yomi Robotic System
K251835 · PLV
Neocis, Inc.
Dental · 116d
Cleared Oct 10, 2025
EvoEndo Single-Use Endoscopy System
K251708 · FDS
EvoEndo, Inc.
Gastroenterology & Urology · 129d
Cleared Oct 10, 2025
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
K251602 · OWB
Canon Medical Systems Corporation
Radiology · 136d
Cleared Oct 10, 2025
HYDROS Robotic System (HY1000)
K251082 · PZP
Procept Biorobotics
Gastroenterology & Urology · 184d
Cleared Oct 10, 2025
Single Use Electrosurgical Knife (KD-612L, KD-612U)
K250351 · KNS
Olympus Medical Systems Corporation
Gastroenterology & Urology · 245d
Cleared Oct 10, 2025
Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated...
K250249 · GMQ
Gold Standard Diagnostics, LLC
Microbiology · 256d
Cleared Oct 10, 2025
On Call® Sure GK Blood Glucose & Ketone Monitoring System
K250085 · NBW
ACON Laboratories, Inc.
Chemistry · 270d
Cleared Oct 10, 2025
SoClean 3+
K243815 · QXQ
Soclean, Inc.
General Hospital · 303d
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