Search FDA 510(k) Database

6,772 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
13345–13368 of 174,061
Cleared Jan 20, 2022
Surgical isolation gown
K212357 · FYC
Wuhan Zonsen Medical Products Co., Ltd.
General Hospital · 175d
Cleared Jan 20, 2022
Flexible Video-Uretero-Renoscope SSU System
K212458 · FGB
Karl Storz Endoscopy America
Gastroenterology & Urology · 168d
Cleared Jan 20, 2022
Gas-Chex Indicator
K212592 · JOJ
Propper Manufacturing Co., Inc.
General Hospital · 157d
Cleared Jan 20, 2022
Disposable Dual Action Tissue Clip
K212748 · PKL
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 143d
Cleared Jan 20, 2022
Electric breast pump
K212884 · HGX
Dongguan Rongfeng Medical Co., Ltd.
Obstetrics & Gynecology · 132d
Cleared Jan 20, 2022
Porous Patella
K212941 · MBH
Encore Medical, L.P. Dba Djo Surgical
Orthopedic · 127d
Cleared Jan 20, 2022
Goody Gloves, Wincare, TBG Gloves
K213075 · LZA
Thai Rubber Gloves Co., Ltd.
General Hospital · 119d
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