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
265–288 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 2026
BracePaste Prime Plus
K261840 · DYH
American Orthodontics
Dental · 1d
Cleared Jun 03, 2026
VSP System (Titanium Palatal Splint)
K261826 · DZJ
3D Systems, Inc.
Dental · 2d
Cleared Jun 03, 2026
iiSure Infusion Set
K261530 · FPA
Deka Research and Development
Chemistry · 26d
Cleared Jun 03, 2026
BioWave BioWraps
K261522 · GXY
Biowave Corporation
Neurology · 27d
Cleared Jun 03, 2026
Tissue Approximation System
K261484 · GAR
Tas Medical, Inc.
General & Plastic Surgery · 29d
Cleared Jun 03, 2026
Permatage Flowable, Settable Hemostatic Bone Paste
K261439 · MTJ
Orthocon, Inc.
Orthopedic · 34d
Cleared Jun 03, 2026
Nitrile Disposable Examination Gloves
K260806 · LZA
Vista Industries,, LLC
General Hospital · 83d
Cleared Jun 03, 2026
HeartFocus
K260780 · QJU
Deski
Radiology · 85d
Cleared Jun 03, 2026
Straumann® ProClean™ Cassette (041.800
K260726 · KCT
Institut Straumann AG
General Hospital · 90d
Cleared Jun 03, 2026
CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)
K260715 · OHS
The Beauty Tech Group, Ltd.
General & Plastic Surgery · 90d
Cleared Jun 03, 2026
Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy...
K260703 · LZA
S&S Glove Corporation
General Hospital · 91d
Cleared Jun 03, 2026
MeRT System
K260402 · SIG
Wave Neuroscience
Neurology · 117d
Cleared Jun 03, 2026
Electric Wheelchair (DF506)
K260373 · ITI
Jiangsu Yveelt Medical Equipment Co.,...
Physical Medicine · 118d
Cleared Jun 03, 2026
VITA Multi-Function Head Brush (TB-2343F, TB-2442F)
K260179 · NFO
Touchbeauty Beauty & Health...
Neurology · 133d
Cleared Jun 03, 2026
CustoMED Viewer
K260116 · LLZ
CustoMED , Ltd.
Radiology · 140d
Cleared Jun 03, 2026
Roosin Collagen Powder
K254034 · KGN
Roosin Medical Co., Ltd.
General & Plastic Surgery · 169d
Cleared Jun 03, 2026
Roosin Collagen Dressing
K253974 · KGN
Roosin Medical Co., Ltd.
General & Plastic Surgery · 174d
Cleared Jun 03, 2026
Scooter (YD-03)
K253600 · INI
Yurob Rehabilitation Medical Co., Ltd.
Physical Medicine · 197d
Cleared Jun 03, 2026
Upper arm electronic blood pressure monitor (XB-01)
K253124 · DXN
Shenzhen Ziqing Medical Equipment...
Cardiovascular · 251d
Cleared Jun 03, 2026
SIC Abutments including CAD/CAM Solutions
K252904 · NHA
Sic Invent AG
Dental · 265d
Cleared Jun 03, 2026
SteriTite Container System with MediTray Products
K252854 · KCT
Case Medical, Inc.
General Hospital · 268d
Cleared Jun 03, 2026
KARL STORZ Endoscopic Accessories for Urology
K252800 · OCZ
Karl Storz SE & CO. KG
Gastroenterology & Urology · 273d
Cleared Jun 02, 2026
Cube 4D Navigation System, VirtuEye Pro
K261540 · PGW
Fiagon GmbH
Ear, Nose, Throat · 25d
Cleared Jun 02, 2026
DIAFIL
K261093 · EBF
DiaDent Group International
Dental · 61d