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: 2026–2026 ×
1,642 results
1345–1368 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
Cleared Feb 09, 2026
Ceribell Instant EEG Headset
K254033 · GXY
Ceribell, Inc.
Neurology · 55d
Cleared Feb 09, 2026
Holter ECG and ABP system (HolterABP)
K251591 · DQK
Edan Instruments, Inc.
Cardiovascular · 262d
Cleared Feb 06, 2026
LiveMedica Enterprise PACS
K253927 · LLZ
Live Medica, LLC
Radiology · 60d
Cleared Feb 06, 2026
MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile...
K253852 · GAM
Ethicon, Inc.
General & Plastic Surgery · 66d
Cleared Feb 06, 2026
SIGNA™ Bolt
K253780 · LNH
Ge Medical Systems, LLC
Radiology · 72d
Cleared Feb 06, 2026
Hood DH-084STR
K253568 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 81d
Cleared Feb 06, 2026
Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
K253221 · IYO
Eieling Technology (Shenzhen) Limited
Radiology · 130d
Cleared Feb 06, 2026
Q Interbody Instruments
K252873 · OLO
K2m, Inc.
Orthopedic · 149d
Cleared Feb 06, 2026
Spine Guidance 5.3 Software
K252871 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 149d
Cleared Feb 06, 2026
IntelliVue Multi-Measurement Module X3 (867030)
K252726 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 162d
Cleared Feb 06, 2026
Kneevoice Cartilage Evaluation System (750-3600-001)
K252076 · DQD
Kneevoice, Inc.
Cardiovascular · 219d
Cleared Feb 06, 2026
ROSA Knee System with UltraSound Imaging Platform (USIP)
K252058 · OLO
Balmoral Medical, LLC
Orthopedic · 220d
Cleared Feb 06, 2026
Dermatrix Duo
K251836 · GEI
Shenzhen Gsd Technology Co., Ltd.
General & Plastic Surgery · 235d