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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
13993–14016 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 2022
ParaMotion
K203761 · IPL
Powerbasetec GmbH
Physical Medicine · 394d
Cleared Jan 21, 2022
Infrared Thermometer
K211752 · FLL
Beijing Choice Electronic Technology...
General Hospital · 228d
Cleared Jan 21, 2022
Powder Free Nitrile Patient Examination Gloves, Blue Color
K211864 · LZA
Siyang Jaysun Medtech Co., Ltd.
General Hospital · 219d
Cleared Jan 21, 2022
OSSIOfiber® Staple
K212594 · MNU
OSSIO , Ltd.
Orthopedic · 158d
Cleared Jan 21, 2022
Osteorevive
K212991 · MQV
Bone Solutions, Inc.
Orthopedic · 123d
Cleared Jan 21, 2022
Nitrile Examination Gloves
K213044 · LZA
Jiangsu Huayuan Medical Technology...
General Hospital · 121d
Cleared Jan 21, 2022
Saremco Print CROWNTEC
K213343 · EBF
Saremco Dental AG
Dental · 106d
Cleared Jan 21, 2022
VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM
K213412 · JOJ
Steris Corparation
General Hospital · 94d
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