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

Filters: Cleared only ×
175,820 results
25801–25824 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 2018
ANEROID SPHYGMOMANOMETER
K173246 · DXQ
Wenzhou Bokang Instruments Co., Ltd.
Cardiovascular · 236d
Cleared May 30, 2018
KATOR Suture Anchor
K173269 · MBI
Kator, LLC
Orthopedic · 230d
Cleared May 30, 2018
Pure Flow External Counter-Pulsation Device
K173483 · DRN
Xtreem Pulse, LLC
Cardiovascular · 198d
Cleared May 30, 2018
Legend Acetabular Liners
K173951 · LPH
Ortho Development Corporation
Orthopedic · 154d
Cleared May 30, 2018
Playtex Stella Tampons
K180167 · HEB
Playtex Manufacturing, Inc.
Obstetrics & Gynecology · 128d
Cleared May 30, 2018
Retia 2
K180293 · MYC
Centervue S.P.A.
Ophthalmic · 118d
Cleared May 30, 2018
MICRORAPTOR REGENESORB Suture Anchor
K180361 · MAI
Smith and Nephew, Inc.
Orthopedic · 110d
Cleared May 30, 2018
EVEREST Spinal System
K181188 · NKB
K2m, Inc.
Orthopedic · 27d
Cleared May 29, 2018
SpineKure Kyphoplasty System
K172871 · NDN
Hanchang Co., Ltd.
Orthopedic · 250d
Cleared May 29, 2018
Dr's Light2
K173157 · EBZ
Good Doctors Co., Ltd.
Dental · 242d
Cleared CT May 29, 2018
Belun Ring
K180174 · DQA
Belun Technology Company Limited
Anesthesiology · 127d
Cleared May 29, 2018
VERIFY Spore Test Strip for S40 Sterilant
K180553 · OVY
STERIS Corporation
General Hospital · 89d
Cleared May 29, 2018
AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer...
K180572 · IYN
Supersonic Imagine
Radiology · 85d
Cleared May 29, 2018
Tri-Ad 2.0 Adams Tricuspid Band
K181132 · KRH
Medtronic
Cardiovascular · 29d
Cleared May 25, 2018
STAR 65
K172147 · MWI
Skanray Technologies Pvt, Ltd.
Cardiovascular · 312d
Cleared May 25, 2018
DripAssist Plus
K172242 · FLN
Shift Labs, Inc.
General Hospital · 303d
Cleared May 25, 2018
Automatic Tissue Processing Unit
K172717 · MUU
Bsl Co.
General & Plastic Surgery · 259d
Cleared May 25, 2018
Infrared Thermometer
K172889 · FLL
Shenzhen Pacom Medical Instruments...
General Hospital · 246d
Cleared May 25, 2018
SURECELL Gelling Fiber Wound Dressing
K173005 · KGN
Jiangsu Newvalue Medical Producst...
General & Plastic Surgery · 240d
Cleared May 25, 2018
Quantum Pump Console
K173834 · DTQ
Spectrum Medical , Ltd.
Cardiovascular · 158d
Cleared May 25, 2018
VORTRAN Cuff Inflator (VCI)
K173914 · BSK
Vortran Medical Technology 1, Inc.
Anesthesiology · 154d
Cleared CT May 25, 2018
ClearGuard HD Antimicrobial Barrier Cap
K180111 · PEH
Pursuit Vascular, Inc.
Gastroenterology & Urology · 129d
Cleared May 25, 2018
TransEnterix Senhance Surgical System
K180163 · NAY
Transenterix, Inc.
General & Plastic Surgery · 126d
Cleared May 25, 2018
inui In-Home Urine Analysis Test System
K180356 · JIL
Scanadu, Inc.
Chemistry · 106d