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
13801–13824 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 2022
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use...
K213440 · LZA
Luliang Hongruida Health Protection...
General Hospital · 116d
Cleared Feb 18, 2022
Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E
K213503 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 109d
Cleared Feb 18, 2022
Vinyl/Nitrile Blend Exam Glove
K213634 · LYZ
Dezhou Hengchang Medical Technology...
General Hospital · 93d
Cleared Feb 18, 2022
Nitrile Examination Gloves (Model: ZMG1351)
K213688 · LZA
Wuhan Zonsen Medical Products Co., Ltd.
General Hospital · 87d
Cleared Feb 18, 2022
Deep Learning Image Reconstruction
K213999 · JAK
Ge Medical Systems, LLC
Radiology · 59d
Cleared Feb 18, 2022
Dental Zirconia Pre-shaded Block
K214003 · EIH
Shenzhen Yurucheng Dental Materials...
Dental · 59d
Cleared Feb 18, 2022
Zirconia Dental Ceramics
K214005 · EIH
Shenzhen Yurucheng Dental Materials...
Dental · 59d
Cleared Feb 18, 2022
Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent...
K220162 · DHB
Hycor Biomedical
Immunology · 29d
Cleared Feb 17, 2022
Titan Condoms
K210208 · HIS
Titan Condoms, LLC
Obstetrics & Gynecology · 387d
Cleared Feb 17, 2022
Safety Pen Needle
K210864 · FMI
Sandstone Medical (Suzhou), Inc.
General Hospital · 331d
Cleared Feb 17, 2022
LoFric Elle
K211212 · EZD
Dentsply Sirona
Gastroenterology & Urology · 300d
Cleared Feb 17, 2022
Xtractor device
K211679 · DRE
Xcardia Innovation , Ltd.
Cardiovascular · 261d
Cleared Feb 17, 2022
Amazing+
K212586 · LZA
Amazing Rubber Products Pvt, Ltd.
General Hospital · 185d
Cleared Feb 17, 2022
Bluezone Model RX-450 Air Purifier
K212824 · FRA
Bluezone Products, Inc.
General Hospital · 167d
Cleared Feb 17, 2022
SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands
K212977 · DQO
Cordis Corporation
Cardiovascular · 153d
Cleared Feb 17, 2022
Powder Free Blue Nitrile Examination Gloves
K213107 · LZA
Novid Ppe Sdn. Bhd.
General Hospital · 146d
Cleared Feb 17, 2022
Vinyl Examination Gloves
K213625 · LYZ
Dezhou Hengchang Medical Technology...
General Hospital · 92d
Cleared Feb 17, 2022
Durex Patronus Wide
K213647 · HIS
Rb Health (Us), LLC
Obstetrics & Gynecology · 90d
Cleared Feb 17, 2022
Voluson P6, Voluson P8
K213689 · IYN
Ge Healthcare
Radiology · 86d
Cleared Feb 17, 2022
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
K213710 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 85d
Cleared Feb 17, 2022
Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab...
K213972 · DQK
Ge Healthcare Information...
Cardiovascular · 59d
Cleared Feb 17, 2022
Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires
K213982 · HTY
Pacific Instruments
Orthopedic · 59d
Cleared Feb 17, 2022
Accu-Chek Softclix Blood Lancing System
K214022 · QRL
Roche Diabetes Care, Inc.
General & Plastic Surgery · 57d
Cleared Feb 17, 2022
YandR System, VoluDerm Handpiece, VoluDerm Tips
K220124 · GEI
Pollogen, Ltd.
General & Plastic Surgery · 30d