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
10945–10968 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 08, 2023
NIRA Model 2
K222685 · OHS
Dermal Photonics Corp
General & Plastic Surgery · 155d
Cleared Feb 08, 2023
Access Cortisol
K223038 · CGR
Beckman Coulter, Inc.
Chemistry · 132d
Cleared Feb 08, 2023
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
K223304 · FYC
Xiamen Probtain Medical Technology...
General Hospital · 104d
Cleared Feb 07, 2023
SAVE GBR
K222451 · NHA
Dentis Co., Ltd.
Dental · 176d
Cleared Feb 07, 2023
Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp...
K222928 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 134d
Cleared Feb 07, 2023
EVOLUTION SPINE Interbody System
K223146 · OVD
Evolution Spine
Orthopedic · 125d
Cleared Feb 07, 2023
Medical Protective Masks
K223686 · FXX
Qinhuangdao Taizhi Medical Technology...
General Hospital · 60d
Cleared Feb 06, 2023
Eminent Spine 3D Cervical Interbody Fusion System
K212701 · ODP
Eminent Spine
Orthopedic · 530d
Cleared Feb 06, 2023
ClotTriever Thrombectomy System
K221531 · QEW
Inari Medical, Inc.
Cardiovascular · 256d
Cleared Feb 06, 2023
Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
K221980 · LYZ
Ever Global (Vietnam) Enterprise...
General Hospital · 216d
Cleared Feb 06, 2023
Care Team Portal
K222398 · DRG
Vivify Health, Inc.
Cardiovascular · 182d
Cleared Feb 06, 2023
Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
K222955 · DJG
Xenta Biomedical Science Co., Ltd.
Toxicology · 132d
Cleared Feb 06, 2023
Nerivio
K223169 · QGT
Theranica Bioelectronics , Ltd.
Neurology · 118d
Cleared Feb 06, 2023
Videa Perio Assist
K223296 · QIH
Videahealth, Inc.
Radiology · 103d
Cleared Feb 06, 2023
Powder Free Blue Nitrile Examination Glove
K223444 · LZA
S&S Glove Corporation
General Hospital · 84d
Cleared Feb 06, 2023
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic...
K223735 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 55d
Cleared Feb 06, 2023
ScanX Swift 2.0, ScanX Swift View 2.0
K230095 · MUH
Durr Dental SE
Radiology · 25d
Cleared Feb 06, 2023
3M™ VitCal Liner/Base
K230270 · EJK
3M Espe Dental Products
Dental · 6d
Cleared Feb 04, 2023
COPAL knee moulds
K222570 · JWH
Heraeus Medical GmbH
Orthopedic · 165d
Cleared Feb 04, 2023
Simparo Anchor Line Fixation System
K222574 · MBI
Simparo, Inc.
Orthopedic · 163d
Cleared Feb 03, 2023
BIOFIRE SPOTFIRE Respiratory (R) Panel
K213954 · QOF
Biofire Diagnostics
Microbiology · 413d
Cleared Feb 03, 2023
Manta Ray TDF Spacer
K220296 · ODP
SeaSpine Orthopedics Corporation
Orthopedic · 366d
Cleared Feb 03, 2023
GaiaBone Bioabsorbable Bone Graft
K220337 · MQV
Corliber (Shenzhen) Medical Device...
Orthopedic · 361d
Cleared Feb 03, 2023
Duoblade
K220996 · GEI
Cnc Technologies
General & Plastic Surgery · 305d