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
14521–14544 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 20, 2022
Entuit PEG, Entuit PEGJ
K213356 · PIF
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 100d
Cleared Jan 20, 2022
SIGNA Hero
K213668 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 59d
Cleared Jan 20, 2022
SIGNA PET/MR
K213709 · OUO
Ge Medical Systems, LLC
Radiology · 57d
Cleared Jan 20, 2022
syngo.CT Extended Functionality
K214019 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Jan 20, 2022
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
K214084 · OAS
Cefla S.C.
Radiology · 24d
Cleared Jan 19, 2022
Franz Zirconia Dental Crown
K203072 · ELL
Franz Biotech, Inc.
Dental · 467d
Cleared Jan 19, 2022
Caption Interpretation Automated Ejection Fraction Software
K210747 · QIH
Caption Health
Radiology · 313d
Cleared Jan 19, 2022
SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove
K211003 · LZA
Showa Best Glove, Inc.
General Hospital · 292d
Cleared Jan 19, 2022
R3 Large Head Liners
K211330 · LPH
Smith & Nephew, Inc.
Orthopedic · 261d
Cleared Jan 19, 2022
Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33
K211532 · DXN
Yibin Junxin Electronics Technology...
Cardiovascular · 246d
Cleared Jan 19, 2022
Stern Fix Sternal Stabilization System
K211613 · JDQ
Neos Surgery S.L
Orthopedic · 238d
Cleared Jan 19, 2022
Biotres
K211709 · MWJ
Biotricity
Cardiovascular · 230d
Cleared Jan 19, 2022
Follicle Clarity
K212012 · QIH
Cycle Clarity
Radiology · 205d
Cleared Jan 19, 2022
MDx-Chex for BCID2
K212576 · PMN
Streck, Inc.
Microbiology · 156d
Cleared Jan 19, 2022
VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System
K212581 · HRS
Stryker GmbH
Orthopedic · 156d
Cleared Jan 19, 2022
Celeris, Disposable Sinus Debrider
K212650 · ERL
Gyrus Acmi, Inc.
Ear, Nose, Throat · 149d
Cleared Jan 19, 2022
GLOBAL ICON Stemless Shoulder System
K212683 · PKC
Depuy(Ireland)
Orthopedic · 148d
Cleared Jan 19, 2022
Disposable Medical Mask
K212826 · FXX
Jiangsu Nanfang Medical Co., Ltd.
General Hospital · 138d
Cleared Jan 19, 2022
Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs)
K213227 · LZA
Uweport, LLC
General Hospital · 112d
Cleared Jan 19, 2022
Jabra Enhance Plus
K213424 · QDD
GN Hearing A/S
Ear, Nose, Throat · 90d
Cleared Jan 19, 2022
3D Bolus Software Application, 3D Brachy Software Application,...
K213438 · MUJ
Adaptiiv
Radiology · 89d
Cleared Jan 19, 2022
LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.
K213447 · OAP
Shenzhen Cosbeauty Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared Jan 19, 2022
CoreLink Navigation Instruments
K214059 · OLO
Corelink, LLC
Orthopedic · 23d
Cleared Jan 18, 2022
CHIRANA Insulin Syringes
K201044 · FMF
Chirana T. Injecta
General Hospital · 637d