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

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175,820 results
14905–14928 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 17, 2022
Lunderquist Extra Stiff Wire Guide
K220137 · DQX
William Cook Europe Aps
Cardiovascular · 30d
Cleared Feb 17, 2022
TENS & PMS (Model: SM9126)
K220150 · NUH
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 29d
Cleared Feb 17, 2022
Digital Intraoral X-ray Sensor
K220277 · MUH
Shenzhen Xpectvision Technology Co.,...
Radiology · 17d
Cleared Feb 16, 2022
Broncoflex Agile, Broncoflex Vortex, Screeni
K212886 · EOQ
Axess Vision Technology
Ear, Nose, Throat · 159d
Cleared Feb 16, 2022
LumiVy Lumbar IBF System
K212930 · MAX
Vy Spine, LLC
Orthopedic · 155d
Cleared Feb 16, 2022
NovoFlow Reinforced Ureteral Stent
K213186 · FAD
Coloplast Corp.
Gastroenterology & Urology · 140d
Cleared Feb 16, 2022
Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL,...
K213533 · IRP
Bio Compression Systems, Inc.
Physical Medicine · 103d
Cleared Feb 16, 2022
14HQ901G-B
K214044 · MQB
Lg Electronics.Inc
Radiology · 51d