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
11785–11808 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 2022
Spinal Inner Fixation System
K222031 · NKB
Changzhou Geasure Medical Apparatus...
Orthopedic · 109d
Cleared Oct 28, 2022
Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20,...
K222191 · IYN
Supersonic Imagine
Radiology · 98d
Cleared Oct 28, 2022
Stela Automix System
K222581 · EBF
Sdi Limited
Dental · 63d
Cleared Oct 28, 2022
Stela Capsule System
K222583 · EBF
Sdi Limited
Dental · 63d
Cleared Oct 28, 2022
JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System
K222653 · NJD
Smith & Nephew, Inc.
Orthopedic · 57d
Cleared Oct 28, 2022
VS3-Iridium System (VS3-IR)
K223020 · OWN
Visionsense, Ltd.
General & Plastic Surgery · 29d
Cleared Oct 28, 2022
ALLY II Uterine Positioning System™ (UPS)
K223064 · LKF
CooperSurgical, Inc.
Obstetrics & Gynecology · 28d
Cleared Oct 28, 2022
Remi Robotic Navigation System
K223070 · OLO
Fusion Robotics, LLC
Orthopedic · 28d
Cleared Oct 28, 2022
Stage
K223079 · LNH
Spintech, Inc.
Radiology · 28d
Cleared Oct 28, 2022
Bakri Essential Postpartum Balloon
K223098 · OQY
Cook Incorporated
Obstetrics & Gynecology · 28d
Cleared Oct 27, 2022
ORAcollect®•Dx
K212745 · OYJ
DNA Genotek, Inc.
Chemistry · 423d
Cleared Oct 27, 2022
uMR Omega with uWS-MR-MRS
K220332 · LNH
Shanghai United Imaging Healthcare...
Radiology · 265d
Cleared Oct 27, 2022
Arthrex BioSuture
K220880 · GAT
Arthrex, Inc.
General & Plastic Surgery · 216d
Cleared Oct 27, 2022
Architect CMV IgG
K220949 · LFZ
Abbott Laboratories
Microbiology · 209d
Cleared Oct 27, 2022
CUSTMBITE Snoring System
K221322 · LRK
Dental Choice Holdings, LLC
Dental · 174d
Cleared Oct 27, 2022
AlphaID™ At Home Genetic Health Risk Service
K221420 · PTA
Progenika Biopharma S.A., A Grifols...
Immunology · 164d
Cleared Oct 27, 2022
Artemis Proximal Femoral Nail System
K221489 · HSB
Glw, Inc.
Orthopedic · 157d
Cleared Oct 27, 2022
S.I.N. Dental Implant System
K222231 · DZE
S.I.N. ? Sistema DE Implante Nacional...
Dental · 94d
Cleared Oct 27, 2022
HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System
K222282 · HRS
Hospital Equipment Manufacturing Company
Orthopedic · 90d
Cleared Oct 27, 2022
DESS Dental Smart Solutions
K222288 · NHA
Terrats Medical SL
Dental · 90d
Cleared Oct 27, 2022
JR MEDIC
K222348 · LYY
Jr Engineering & Medical Technologies...
General Hospital · 85d
Cleared Oct 27, 2022
CurvaFix IM System
K222505 · HWC
Curvafix, Inc.
Orthopedic · 70d
Cleared Oct 27, 2022
S.I.N. Instrument Kits
K222514 · KCT
S.I.N. ? Sistema DE Implante Nacional...
General Hospital · 69d
Cleared Oct 27, 2022
FilmArray Pneumonia Panel plus
K222601 · QDS
Biofire Diagnostics, LLC
Microbiology · 59d