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
23113–23136 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 2019
Medline Electrocautery Pencil
K190643 · GEI
Medline Industries, Inc.
General & Plastic Surgery · 54d
Cleared May 06, 2019
Biograph Vision
K190900 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared May 06, 2019
BioCardia 8.5 F Avance Steerable lntroducer
K190941 · DYB
Biocardia, Inc.
Cardiovascular · 26d
Cleared May 05, 2019
Wireless Intelligent Thermometer
K182437 · FLL
Shenzhen Jumper Medical Equipment...
General Hospital · 240d
Cleared May 04, 2019
Medline Quick-Clear Wand
K183577 · KNT
Medline Industries, Inc.
Gastroenterology & Urology · 134d
Cleared May 03, 2019
Manual Wheelchair W54
K180309 · IOR
Jiangsu Jumao Medical Equipment Co.,...
Physical Medicine · 455d
Cleared May 03, 2019
armor LC
K182118 · EIE
Mavrik Dental Systems, Ltd.
Dental · 270d
Cleared May 03, 2019
CLEARFIL MAJESTY IC
K182430 · EBF
Kuraray Noritake Dental, Inc.
Dental · 239d
Cleared May 03, 2019
HALF DOME Posterior Lumbar Interbody System
K182877 · MAX
Astura Medical, LLC
Orthopedic · 200d
Cleared May 03, 2019
Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible...
K183188 · FGB
Richard Wolf Medical Instruments...
Gastroenterology & Urology · 165d
Cleared May 03, 2019
Leaf Photocoagulator
K190083 · HQF
Norlase Aps
Ophthalmic · 106d
Cleared May 03, 2019
FilmArray Pneumonia/Pneumoniaplus Control
K190222 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 87d
Cleared May 03, 2019
NeoLSD MSMS Kit
K190266 · PQW
Perkinelmer, Inc.
Chemistry · 84d
Cleared May 03, 2019
AuraGen 123 Suction Lipoplasty System (A123)
K190278 · MUU
Auragen Aesthetics, LLC
General & Plastic Surgery · 84d
Cleared May 03, 2019
Arthrex DynaNite® PIP (Hammertoe) Implant
K190287 · HTY
Arthrex, Inc.
Orthopedic · 81d
Cleared May 03, 2019
MatrixRIB Fixation System
K190409 · HRS
DePuy Synthes
Orthopedic · 71d
Cleared May 03, 2019
Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept...
K190504 · GXI
Relievant Medsystems
Neurology · 63d
Cleared May 03, 2019
RELIEVA ULTIRRA Sinus Balloon Catheter
K190525 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 60d
Cleared May 03, 2019
TruDi NAV Wire
K190532 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 60d
Cleared May 03, 2019
Aptis Medical Distal Radio Ulnar Joint Implant
K190599 · KXE
Aptis Medical, LLC
Orthopedic · 56d
Cleared May 03, 2019
N Latex FLC kappa, N Latex FLC lambda
K190879 · DFH
Siemens Healthcare Diagnostics...
Immunology · 29d
Cleared May 02, 2019
Cocoon Convective Warming System
K181671 · DWJ
Care Essentials Pty, Ltd.
Cardiovascular · 311d
Cleared May 02, 2019
alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN...
K182474 · JFJ
Biosystems S.A.
Chemistry · 234d
Cleared May 02, 2019
TRIO Handpiece
K183199 · GEX
Omniguide, Inc.
General & Plastic Surgery · 164d