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
12073–12096 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 27, 2022
Mobility+ Enteral Feeding System
K222678 · PIF
Rockfield Medical
Gastroenterology & Urology · 51d
Cleared Oct 27, 2022
2008T BlueStar Hemodailysis Machine
K222952 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 30d
Cleared Oct 27, 2022
Cirq Arm System (2.0)
K222966 · OLO
Brainlab AG
Orthopedic · 30d
Cleared Oct 26, 2022
Eclipse Blood Collection Set
K213690 · JKA
Eclipse Medcorp, LLC
General Hospital · 337d
Cleared Oct 26, 2022
FIREFLY® Cervical Navigation Guide
K220132 · QSD
Mighty Oak Medical, Inc.
Orthopedic · 281d
Cleared Oct 26, 2022
Preat Abutments
K220823 · NHA
Preat Corporation
Dental · 219d
Cleared Oct 26, 2022
Silverlon Wound Contact, Burn Contact Dressings
K221218 · FRO
Argentum Medical, Inc.
General & Plastic Surgery · 182d
Cleared Oct 26, 2022
Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)
K221374 · LYY
Hebei Titans Hongsen Medical...
General Hospital · 167d
Cleared Oct 26, 2022
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
K221885 · QDJ
23AndMe, Inc.
Chemistry · 119d
Cleared Oct 26, 2022
NEUROMARK System
K222032 · GEI
Neurent Medical
Ear, Nose, Throat · 107d
Cleared Oct 26, 2022
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife...
K222047 · IWB
Elekta Solutions AB
Radiology · 106d
Cleared Oct 26, 2022
DESS Dental Smart Solutions
K222269 · NHA
Terrats Medical SL
Dental · 90d
Cleared Oct 26, 2022
Intracept Intraosseous Nerve Ablation System
K222281 · GXI
Relievant Medsystems, Inc.
Neurology · 89d