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
4801–4824 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 2025
BDC Dental Unit
K242404 · EIA
Bdc Dental Corporation , Ltd.
Dental · 178d
Cleared Feb 07, 2025
Symani Surgical System
K242368 · SAQ
Medical Microinstruments, Inc.
General & Plastic Surgery · 182d
Cleared Feb 07, 2025
ceramys™ femoral head system
K241483 · LZO
Encore Medical, L.P.
Orthopedic · 259d
Cleared Feb 07, 2025
Elecsys sFlt-1 and Elecsys PlGF
K241453 · QWH
Roche Diagnostics
Chemistry · 261d
Cleared Feb 06, 2025
Resolution Clip (M00522600)
K250066 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 27d
Cleared Feb 06, 2025
Celerity Incubator
K250061 · FRC
STERIS Corporation
General Hospital · 27d
Cleared Feb 06, 2025
BPS - Bone Fragment Fixation Plates, Screws and Washers
K250055 · HRS
Orthonovis, Inc.
Orthopedic · 27d
Cleared Feb 06, 2025
Celerity 5 HP Biological Indicator (LCB052)
K250044 · FRC
STERIS Corporation
General Hospital · 27d
Cleared Feb 06, 2025
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use...
K244034 · LZA
Ever Global (Vietnam) Enterprise...
General Hospital · 38d
Cleared Feb 06, 2025
Scorpio Universal Dome Patella
K243817 · JWH
Howmedica Osteonics Corp., Dba...
Orthopedic · 56d
Cleared Feb 06, 2025
EPIQ Series Diagnostic Ultrasound System
K243794 · IYN
Philips Ultrasound, LLC
Radiology · 58d
Cleared Feb 06, 2025
Stryker Orthopaedics Hip Devices Labeling Update
K243784 · LPH
Howmedica Osteonics Corp., Dba...
Orthopedic · 59d
Cleared Feb 06, 2025
VMAT PRO
K243488 · ISA
Termosalud
Physical Medicine · 86d
Cleared Feb 06, 2025
Diode Laser Hair Removal Device (EVOLUTION MEDICAL)
K243465 · GEX
Guangzhou Chuang Zao Mei Technology...
General & Plastic Surgery · 90d
Cleared Feb 06, 2025
Delphi MCS Electrode Cap
K243243 · GXY
Quantalx Neuroscience, Ltd.
Neurology · 118d
Cleared Feb 06, 2025
308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C...
K242977 · FTC
Xuzhou Kernel Medical Equipment Co.,...
General & Plastic Surgery · 133d
Cleared Feb 06, 2025
Unimed Reusable Finger Clip SpO2 Sensors (U103-125)
K242580 · DQA
Unimed Medical Supplies, Inc.
Anesthesiology · 160d
Cleared Feb 06, 2025
Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus,...
K242428 · NGL
Guangzhou Decheng Biotechnology Co.,...
Toxicology · 175d
Cleared Feb 06, 2025
DUTAU-NOVATECH®
K242324 · EOQ
Novatech SA
Ear, Nose, Throat · 184d
Cleared Feb 06, 2025
Disposable Sphincterotome
K242192 · KNS
Beijing Zksk Technology Co., Ltd.
Gastroenterology & Urology · 195d
Cleared Feb 06, 2025
VIVACE
K242111 · HGX
Unimom.Co
Obstetrics & Gynecology · 202d
Cleared Feb 06, 2025
CROSSLEAD 0.014inch
K241702 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 238d
Cleared Feb 06, 2025
Signature Osteosynthesis Plate System
K241599 · HRS
Signature Orthopaedic Pty , Ltd.
Orthopedic · 247d
Cleared Feb 05, 2025
GRYPHON™ X Anchor
K243790 · MAI
Depuy Mitek
Orthopedic · 57d