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
16609–16632 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 2021
Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30
K203700 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 224d
Cleared Jul 30, 2021
Firefly Needleless Connector
K203796 · FPA
Puracath Medical, Inc.
General Hospital · 214d
Cleared Jul 30, 2021
Labat series Diagnostic Ultrasound System
K210154 · IYN
Shenzhen Wisonic Medical Technology...
Radiology · 190d
Cleared Jul 30, 2021
Lab Bag with Fabric Pouch
K210248 · GCJ
Advanced Medical Design Co., Ltd.
General & Plastic Surgery · 182d
Cleared Jul 30, 2021
BD PowerPiCC Catheter
K210264 · LJS
Bard Access Systems, Inc.
General Hospital · 179d
Cleared Jul 30, 2021
Fingertip Pulse Oximeter
K210274 · DQA
Zhuhai Linte Medical Instrument Co.,...
Anesthesiology · 179d
Cleared Jul 30, 2021
Disposable Nitrile Medical Examination Glove
K210691 · LZA
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 144d
Cleared Jul 30, 2021
Wrist Blood Pressure Monitor, Blood Pressure Monitor
K210768 · DXN
Andon Health Co, Ltd.
Cardiovascular · 137d
Cleared Jul 30, 2021
MEO Med Disposable Medical Face Mask
K210870 · FXX
Fujian Meo Medical Technology Limited
General Hospital · 128d
Cleared Jul 30, 2021
PowerDot PD-01MT2 Muscle Stimulator
K210938 · IPF
Smartmissimo Technologies Pte, Ltd.
Physical Medicine · 123d
Cleared Jul 30, 2021
qER-Quant
K211222 · QIH
Qure.Ai Technologies
Radiology · 98d
Cleared Jul 30, 2021
Disposable Nitrile Examination Gloves
K211264 · LZA
Shenzhen Shiqiao Science and...
General Hospital · 95d
Cleared Jul 30, 2021
EMBOTRAP III Revascularization Device
K211338 · NRY
Neuravi, Ltd.
Neurology · 88d
Cleared Jul 30, 2021
syngo.via RT Image Suite
K211379 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 87d
Cleared Jul 30, 2021
Elexir
K211380 · PCC
Nu Eyne Co., Ltd.
Neurology · 87d
Cleared Jul 30, 2021
Powersculp laser lipolysis system
K211402 · PKT
Lotuxs Medtech (Suzhou) Co., Ltd.
General & Plastic Surgery · 85d
Cleared Jul 30, 2021
Pounce Thrombectomy System
K211492 · QEW
Surmodics,Inc.
Cardiovascular · 78d
Cleared Jul 30, 2021
Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS),...
K211710 · NKG
Orthofix, Inc.
Orthopedic · 57d
Cleared Jul 30, 2021
UltraLase Flexible CO2 Laser Waveguide
K211761 · GEX
W & R Investments, LLC Dba Laser...
General & Plastic Surgery · 52d
Cleared Jul 30, 2021
DX-D Imaging Package with XD Detectors
K211790 · MQB
Agfa N.V.
Radiology · 50d
Cleared Jul 30, 2021
FibroScan 230
K212035 · IYO
Echosens
Radiology · 30d
Cleared Jul 29, 2021
BTI Extra-Short Dental Implant System UnicCa
K202825 · DZE
B.T.I. Biotechnology Institute, Sl.
Dental · 308d
Cleared Jul 29, 2021
Straumann Surgical Cassettes
K203753 · KCT
Straumann USA, LLC
General Hospital · 218d
Cleared Jul 29, 2021
FiteBac CC OrthoSeal
K210115 · DYH
Largent Health, LLC
Dental · 191d