FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
1321–1344 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 2026
Healgen® Accurate Oral Fluid Drug Test COT/THC
K252523 · NFW
Healgen Scientific, LLC
Toxicology · 185d
Cleared Feb 12, 2026
Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)
K252490 · FMK
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 188d
Cleared Feb 12, 2026
Well-Life Incontinence Stimulation System (WL-2405i(P))
K251760 · KPI
Well-Life Healthcare , Ltd.
Gastroenterology & Urology · 248d
Cleared Feb 12, 2026
Wrist Fracture System
K251732 · HRS
Met One Technologies, LLC
Orthopedic · 251d
Cleared Feb 12, 2026
PuraCath Firefly Needleless Connector IT (9005)
K251375 · FPA
Puracath Medical, Inc.
General Hospital · 286d
Cleared Feb 11, 2026
iFuse INTRA Ti™ Implant System
K253488 · OUR
SI-BONE, Inc.
Orthopedic · 110d
Cleared Feb 11, 2026
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona...
K253049 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 142d
Cleared Feb 11, 2026
AXS Lift Intracranial Base Catheter
K253032 · QJP
Stryker Neurovascular
Neurology · 142d
Cleared Feb 11, 2026
AI4CMR v2.0
K252084 · QIH
Ai4medimaging Medical Solutions S.A.
Radiology · 224d
Cleared Feb 11, 2026
ArmSure Fluoroscopic Positioning System
K251992 · OWB
Savfe Co. , Ltd.
Radiology · 229d
Cleared Feb 11, 2026
CURIS II RF Generator (REF 360100-05)
K251813 · GEI
Sutter Medizintechnik GmbH
General & Plastic Surgery · 243d
Cleared Feb 11, 2026
SteriHub™ Disinfecting Device and Protective Cover
K251592 · QBP
1World Vista Medical
General Hospital · 264d
Cleared Feb 10, 2026
SpaceOAR Vue System (SV-2101)
K260119 · OVB
Boston Scientific Corporation
Radiology · 27d
Cleared Feb 10, 2026
XT3 System
K260073 · JDW
Biodynamik, Inc.
Orthopedic · 32d
Cleared Feb 10, 2026
MI View&GO
K254016 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 57d
Cleared Feb 10, 2026
Vulcan Spinal System
K253545 · NKB
K2m, Inc.
Orthopedic · 88d
Cleared Feb 10, 2026
CollOvine™ Wound Powder
K253140 · KGN
Ovigenex, LLC
General & Plastic Surgery · 138d
Cleared Feb 10, 2026
Earflo (EF001)
K252751 · MJV
Earflo, Inc.
Ear, Nose, Throat · 165d
Cleared Feb 10, 2026
multiFlux 130 (F00013123)
K252459 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 189d
Cleared Feb 10, 2026
GEM Flex Coil 16-L Array, 1.5T Receive Only
K252179 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 214d
Cleared Feb 10, 2026
LANDR Contact LENS Case
K252175 · LRX
Fourth Axis, LLC
Ophthalmic · 214d
Cleared Feb 10, 2026
NIM Essence™ EMG Endotracheal Tube (NIMEID060)
K251672 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 256d
Cleared Feb 10, 2026
Solidex® Ti-Links and Screws
K251515 · NHA
CreoDent Hudson Valley
Dental · 270d
Cleared Feb 09, 2026
Peel-Away Introducer Sheath
K254236 · DYB
VascuTech Medical, LLC
Cardiovascular · 42d