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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
8521–8544 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 2023
Modius Sleep
K230826 · QJQ
Neurovalens , Ltd.
Neurology · 217d
Cleared Oct 27, 2023
PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA,...
K230490 · OLP
Dongguan Hunter Electronic Technology...
General & Plastic Surgery · 246d
Cleared Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K230300 · JFP
Abbott Point of Care, Inc.
Chemistry · 266d
Cleared Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K230285 · CHL
Abbott Point of Care, Inc.
Chemistry · 267d
Cleared Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K230275 · JGS
Abbott Point of Care, Inc.
Chemistry · 268d
Cleared Oct 27, 2023
Cold/Hot Compression
K223541 · IRP
Jkh Health Co., Ltd.
Physical Medicine · 336d
Cleared Oct 27, 2023
Centrix FluoroSilver Silver Diamine Fluoride 38%
K222459 · PHR
Centrix, Inc.
Dental · 438d
Cleared Oct 27, 2023
Plaxpot Multi Plasma
K220493 · QVJ
Gcs Co. Limited
General & Plastic Surgery · 612d
Cleared Oct 27, 2023
Safety butterfly type blood collection needle, Butterfly type blood...
K213146 · JKA
Jiangsu Rongye Technology Co., Ltd.
General Hospital · 760d
Cleared Oct 26, 2023
AllTest Fentanyl Urine Test Cassette
K233417 · NGL
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 16d
Cleared Oct 26, 2023
PressON Spinal Fixation System
K233234 · NKB
Nexus Spine, LLC
Orthopedic · 28d
Cleared Oct 26, 2023
OGmend® Implant Enhancement System
K233223 · QVI
Woven Orthopedic Technologies
Orthopedic · 28d
Cleared Oct 26, 2023
cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP)
K233170 · GXH
AtriCure, Inc.
Neurology · 29d
Cleared Oct 26, 2023
Luja Coude (20108 Male CH18 - large packaging)
K233101 · EZD
Coloplast Corp.
Gastroenterology & Urology · 30d
Cleared Oct 26, 2023
Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT)
K233091 · KFM
Qura S.R.L
Cardiovascular · 30d
Cleared Oct 26, 2023
Lumify Diagnostic Ultrasound System
K232500 · IYN
Philips Ultrasound
Radiology · 70d
Cleared Oct 26, 2023
SIMDA abutment
K232271 · NHA
Simda Co., Ltd.
Dental · 87d
Cleared Oct 26, 2023
ANAX™ 5.5 Spinal System
K231737 · NKB
Innosys Co., Ltd.
Orthopedic · 134d
Cleared Oct 26, 2023
TE Air Diagnostic Ultrasound System
K231685 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 139d
Cleared Oct 26, 2023
Electric Breast Pump
K231595 · HGX
Shenzhen Changkun Technology Co., Ltd.
Obstetrics & Gynecology · 147d
Cleared Oct 26, 2023
MOLLI 2
K231579 · NEU
Molli Surgical, Inc.
General & Plastic Surgery · 148d
Cleared Oct 26, 2023
Sontro® OTC Hearing Aids (AI)
K231550 · QUH
Soundwave Hearing, LLC
Ear, Nose, Throat · 149d
Cleared Oct 26, 2023
Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs,...
K230662 · LZA
Zhonghong Pulin Medical Products Co.,...
General Hospital · 230d
Cleared Oct 26, 2023
Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230),...
K230559 · BTT
Medline Industries, Inc.
Anesthesiology · 240d