Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
31801–31824 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 2016
SANDMAN ELITE
K153353 · OLZ
Embla Systems
Neurology · 216d
Cleared Jun 23, 2016
Quiver Laparoscopic Extendable
K153472 · HAM
Itl Corporation Pty, Ltd.
General & Plastic Surgery · 204d
Cleared Jun 23, 2016
Chocolate XD PTCA Balloon Catheter
K153682 · LOX
Trireme Medical, LLC
Cardiovascular · 184d
Cleared Jun 23, 2016
StatStrip Xpress Blood Glucose Monitoring System
K160156 · NBW
Nova Biomedical Corporation
Chemistry · 153d
Cleared Jun 23, 2016
The Life Spine Subtalar Implant System
K160169 · HWC
Life Spine
Orthopedic · 148d
Cleared Jun 23, 2016
Synthetic Vinyl Examination Gloves, Powder-Free, Yellow
K160468 · LYZ
Inpro Technology Device Factory
General Hospital · 125d
Cleared Jun 23, 2016
FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM
K160540 · BZE
Flexicare Medical Limited.
Anesthesiology · 118d
Cleared Jun 23, 2016
JustRight Surgical Vessel Sealing System
K160602 · GEI
Justright Surgical
General & Plastic Surgery · 113d
Cleared Jun 23, 2016
NIO-P
K160805 · FMI
Waismed, Ltd.
General Hospital · 92d
Cleared Jun 23, 2016
NC Quantum Apex PTCA Dilatation Catheter
K160823 · LOX
Boston Scientific Corporation
Cardiovascular · 90d
Cleared Jun 23, 2016
Latera Absorbable Nasal Implant
K161191 · NHB
Spirox, Inc.
Ear, Nose, Throat · 57d
Cleared Jun 23, 2016
Kuvia3D
K161559 · LLZ
4qimaging, LLC Dba Qmetrics
Radiology · 17d
Cleared Jun 22, 2016
Portable ECG Monitor
K152863 · DPS
Contec Medical Systems Co.,Ltd
Cardiovascular · 266d
Cleared Jun 22, 2016
NERBRIDGE
K152967 · JXI
Toyobo Co., Ltd.
Neurology · 258d
Cleared Jun 22, 2016
Portable Slit Lamp
K153545 · HJO
Shanghai Bolan Optical-Electric Co.,...
Ophthalmic · 194d
Cleared Jun 22, 2016
Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml
K153569 · JWY
Liofilchem S. R. L.
Microbiology · 190d
Cleared Jun 22, 2016
OptiCross 18, 30 MHz Peripheral Imaging Catheter
K160514 · OBJ
Boston Scientific Corporation
Cardiovascular · 119d
Cleared Jun 22, 2016
IMPAX Volume Viewing 4.0
K161061 · LLZ
Agfa Healthcare N.V.
Radiology · 68d
Cleared Jun 22, 2016
PolypVac Microdebrider (3.3mm and 4.0mm)
K161101 · ERL
Laurimed, LLC
Ear, Nose, Throat · 64d
Cleared Jun 22, 2016
CliniCloud Non-contact Thermometer, Model SPL1024
K161325 · FLL
Stethocloud Pty.Ltd (Clinicloud)
General Hospital · 41d
Cleared Jun 22, 2016
Target Detachable Coils
K161429 · HCG
Stryker Neurovascular
Neurology · 30d
Cleared Jun 21, 2016
Aquarius Stoma Measuring Device
K152246 · KNT
Degania Silicone , Ltd.
Gastroenterology & Urology · 316d
Cleared Jun 21, 2016
ASAHI Fielder XT-A, ASAHI Fielder XT-R
K153106 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 238d
Cleared Jun 21, 2016
Masimo Root Monitoring System and Accessories
K153225 · MWI
Masimo Corporation
Cardiovascular · 228d