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
11809–11832 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 26, 2022
EsoCheck Cell Collection Device
K222366 · EOX
Lucid Diagnostics, Inc.
Gastroenterology & Urology · 83d
Cleared Oct 26, 2022
Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)
K222498 · LZA
Humanwell Healthcare Group Medical...
General Hospital · 69d
Cleared Oct 26, 2022
VASSALLO GT EXT
K222631 · DQX
Filmecc Co., Ltd.
Cardiovascular · 56d
Cleared Oct 26, 2022
TEMA Elbow system - Line extension
K222807 · JDB
Lima Corporate S.P.A.
Orthopedic · 40d
Cleared Oct 26, 2022
EzRay Air 2 Wall (Model: VEX-S350W)
K223058 · EHD
VATECH Co., Ltd.
Radiology · 26d
Cleared Oct 26, 2022
DigiX FDX
K223060 · KPR
Allengers Medical Systems Limited
Radiology · 26d
Cleared Oct 26, 2022
Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices
K223065 · MAX
Adcura, Inc.
Orthopedic · 26d
Cleared Oct 26, 2022
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)
K223235 · LZA
Pt. Sintong Unigolden Glove
General Hospital · 13d
Cleared Oct 25, 2022
Disposable Surgical Face Mask
K212649 · FXX
Lyncmed Medical Technology (Beijing)...
General Hospital · 428d
Cleared Oct 25, 2022
Hudson RCI Triflo II Incentive Deep Breathing Exerciser
K220565 · BWF
Medline Industries, Inc.
Anesthesiology · 239d
Cleared Oct 25, 2022
JR MEDIC Nitrile Examination Gloves Powder Free- Black
K221169 · LZA
Jr Engineering & Medical Technologies...
General Hospital · 186d