Search FDA 510(k) Database

7,131 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
21361–21384 of 174,061
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
Cleared May 02, 2019
K-Shield Advantage Port Access Infusion Set (PAIS)
K190233 · FPA
Kawasumi Laboratories, Inc.
General Hospital · 85d
Cleared May 02, 2019
PASS LP Spinal System
K190376 · NKB
Medicrea International SA
Orthopedic · 72d
Cleared May 02, 2019
Ponto 4
K190540 · LXB
Oticon Medical AB
Ear, Nose, Throat · 59d
Cleared May 02, 2019
SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model...
K190560 · MUD
Nonin Medical, Inc.
General & Plastic Surgery · 58d
Cleared May 02, 2019
HYDRASHIFT 2/4 daratumumab
K190851 · CFF
Sebia
Immunology · 30d
Cleared May 01, 2019
NS 120P-TRS Airway Pressure Gauge
K180510 · CAP
Instrumentation Industries, Inc.
Anesthesiology · 428d
Cleared May 01, 2019
Brush Biopsy Set
K182231 · FDX
Cook Incorporated
Gastroenterology & Urology · 257d