FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
10489–10512 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 2023
ET Abutment System
K222636 · NHA
Hiossen, Inc.
Dental · 240d
Cleared Apr 28, 2023
Nanox.ARC
K222934 · IZF
Nano-X Imaging , Ltd.
Radiology · 214d
Cleared Apr 28, 2023
Customized Abutment
K223634 · NHA
Arum Dentistry Co., Ltd.
Dental · 144d
Cleared Apr 28, 2023
Titanium Abutment Blank Nobel Biocare N1 TCC
K223677 · NHA
Nobel Biocare AB
Dental · 141d
Cleared Apr 28, 2023
Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp
K223862 · OAP
Wontech Co., Ltd.
General & Plastic Surgery · 126d
Cleared Apr 28, 2023
Q-Rejuvalight Pro Facewear (Model: P19-0023)
K230042 · OHS
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 112d
Cleared Apr 28, 2023
Bladeless Trocar – Artemis Lap Cannula
K230058 · GCJ
T.A.G. Medical Products Corporation,...
General & Plastic Surgery · 109d
Cleared Apr 28, 2023
Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)
K230480 · FZP
Teleflex Medical
General & Plastic Surgery · 65d
Cleared Apr 28, 2023
Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)
K230597 · OAP
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 56d
Cleared Apr 28, 2023
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364)
K230600 · KPS
Spectrum Dynamics Medical, Ltd.
Radiology · 56d
Cleared Apr 28, 2023
Hand Trauma Threaded Nail System
K230908 · HWC
Skeletal Dynamics, Inc.
Orthopedic · 28d
Cleared Apr 28, 2023
Ingenia Elition and MR 7700 MR Systems
K230972 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 23d
Cleared Apr 27, 2023
Myolift QT
K213078 · NFO
Johari Digital Healthcare Limited
Physical Medicine · 581d
Cleared Apr 27, 2023
Cumulus Functional Neurophysiology Platform
K221963 · GWQ
Cumulus Neuroscience Limited
Neurology · 296d
Cleared Apr 27, 2023
Biodegradable Powder Free Nitrile Examination Glove, Blue Color,...
K221983 · LZA
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 295d
Cleared Apr 27, 2023
Epildream HP 4000 MED
K222352 · GEX
D.E.A Project S.R.1.
General & Plastic Surgery · 266d
Cleared Apr 27, 2023
PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker...
K222381 · HRS
Stryker GmbH
Orthopedic · 265d
Cleared Apr 27, 2023
EmPro EPS (EP4514C-190, EP6514C-190)
K222694 · NTE
MicroVention, Inc.
Cardiovascular · 233d
Cleared Apr 27, 2023
ClotTriever XL Catheter
K223210 · QEW
Inari Medical, Inc.
Cardiovascular · 192d
Cleared Apr 27, 2023
Precision DL
K223212 · KPS
Ge Healthcare
Radiology · 192d
Cleared Apr 27, 2023
Gastric Alimetry System
K223398 · MYE
Alimetry , Ltd.
Gastroenterology & Urology · 170d
Cleared Apr 27, 2023
UNIDRIVE SIII System
K223520 · HIH
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 155d
Cleared Apr 27, 2023
ENT EM
K223734 · PGW
Brainlab AG
Ear, Nose, Throat · 135d
Cleared Apr 27, 2023
DentMix VPS Impression Material
K223892 · ELW
Innovative Product Brands, Inc.
Dental · 120d