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
20401–20424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 2020
IQon Spectral CT
K193454 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 42d
Cleared Jan 23, 2020
VINNO 8, VINNO 6, VINNO 5
K190120 · IYN
Vinno Technology (Suzhou) Co.,Ltd
Radiology · 364d
Cleared Jan 23, 2020
FiteBac Cavity Cleanser
K190271 · LBH
Largent Health, LLC
Dental · 349d
Cleared Jan 23, 2020
GammaTile
K190839 · KXK
Gt Medical Technologies
Radiology · 297d
Cleared Jan 23, 2020
Elements Viewer
K191014 · LLZ
Brainlab AG
Radiology · 281d
Cleared Jan 23, 2020
Proneb Max
K191270 · CAF
Pari Respiratory Equipment, Inc.
Anesthesiology · 255d
Cleared Jan 23, 2020
Blue Phantom PT
K191821 · LHN
Iba Dosimetry GmbH
Radiology · 199d
Cleared Jan 23, 2020
STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader
K192025 · FRC
Advanced Sterilization Products (Asp)
General Hospital · 178d
Cleared Jan 23, 2020
Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535
K192092 · DXN
Seca GmbH & Co. KG
Cardiovascular · 171d
Cleared Jan 23, 2020
VistaScan USB Ultrasound Imaging System
K192170 · IYO
Emagine Solutions Technology, LLC
Radiology · 164d
Cleared Jan 23, 2020
EEA Circular Stapler with Tri-Staple Technology
K192330 · GDW
Covidien
General & Plastic Surgery · 149d
Cleared Jan 23, 2020
Bactisure Wound Lavage
K192349 · FQH
Next Science, LLC
General & Plastic Surgery · 147d
Cleared Jan 23, 2020
Healing Abutments and Cover Screws
K192436 · NHA
Dentium Co., Ltd.
Dental · 139d
Cleared Jan 23, 2020
Surefil one Self-adhesive Composite Hybrid
K192530 · EMA
Dentsply Sirona
Dental · 129d
Cleared Jan 23, 2020
Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor
K193295 · MBI
Parcus Medical, LLC
Orthopedic · 57d
Cleared Jan 23, 2020
HardyDisk AST Cefiderocol 30ug (FDC30)
K193504 · JTN
Hardy Diagnostics
Microbiology · 36d
Cleared Jan 22, 2020
Internal Hex Implant System
K190837 · DZE
Ebi, Inc.
Dental · 296d
Cleared Jan 22, 2020
Fundus Camera
K190954 · HKI
Chongqing Bio Newvision Medical...
Ophthalmic · 286d
Cleared Jan 22, 2020
Isopure Dry Acid Dissolution System
K191093 · KPO
Isopure, Corp.
Gastroenterology & Urology · 272d
Cleared Jan 22, 2020
Spectra Q
K191109 · HGX
Uzinmedicare Co.
Obstetrics & Gynecology · 271d
Cleared Jan 22, 2020
E-EEGX, N-EEGX
K191322 · OLT
GE Healthcare Finland Oy
Neurology · 252d
Cleared Jan 22, 2020
FastFit EMS System
K192161 · NGX
Fast Fit, LLC
Physical Medicine · 166d
Cleared Jan 22, 2020
Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion...
K192502 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 132d
Cleared Jan 22, 2020
HydroPearl Microspheres
K192684 · NOY
MicroVention, Inc.
Gastroenterology & Urology · 118d