FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
15097–15120 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 2022
PERLA® TL Posterior Osteosynthesis System
K213470 · NKB
Spineart
Orthopedic · 85d
Cleared Jan 21, 2022
b-ONE MOBIO Total Knee System
K213673 · JWH
B-One Ortho, Corp.
Orthopedic · 60d
Cleared Jan 21, 2022
ETHICON Megadyne Electrosurgical Generator
K213696 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 59d
Cleared Jan 21, 2022
Universal DR 1748
K214030 · MQB
Konica Minolta Healthcare Americas, Inc.
Radiology · 29d
Cleared Jan 20, 2022
Surgical Face Mask
K203161 · FXX
Wuhan Raytex Protection Co., Ltd.
General Hospital · 454d
Cleared Jan 20, 2022
Parkell Self-Adhesive Cement
K210259 · EMA
Parkell, Inc.
Dental · 353d
Cleared Jan 20, 2022
KIDNEY ASSIST-transport
K211333 · KDN
Xvivo Perfusion AB
Gastroenterology & Urology · 262d
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