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
35065–35088 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 2015
SCIg60 Infuser, Infuset
K142319 · PKP
Emed Technologies Corporation
General Hospital · 267d
Cleared May 14, 2015
EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes
K142629 · FDS
Fujifilm Medical System U.S.A., Inc.
Gastroenterology & Urology · 240d
Cleared May 14, 2015
Bookwalter Gordon Adjustable Compression Element
K143078 · DXC
Symmetry Surgical
Cardiovascular · 199d
Cleared May 14, 2015
T.A.G. Dental Implant System
K143326 · DZE
T.A.G. Medical Products Corporation,...
Dental · 175d
Cleared May 14, 2015
Planmed Verity
K143435 · OAS
Planmed OY
Radiology · 164d
Cleared May 14, 2015
Tinnitus Sound Generator Module
K150171 · KLW
Gn Resound A/S
Ear, Nose, Throat · 108d
Cleared May 14, 2015
Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere
K150458 · PHX
Exactech, Inc.
Orthopedic · 80d
Cleared May 13, 2015
MDK HANDPIECES
K141886 · EFB
Modern Korea Co., Ltd.
Dental · 303d
Cleared May 13, 2015
SpineFrontier Lumbar Interbody Fusion Device System
K142504 · MAX
Spinefrontier, Inc.
Orthopedic · 250d
Cleared May 13, 2015
Hematocrit and Metabolite QUALICHECK
K150226 · JJS
Radiometer Medical Aps
Chemistry · 100d
Cleared May 13, 2015
IntelliVue Patient Monitor
K150310 · DSI
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 93d
Cleared May 13, 2015
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
K150356 · JXM
Healgen Scientific, LLC
Chemistry · 90d
Cleared May 13, 2015
JMS Harmony A.V. Fistula Needle Set
K151017 · FIE
JMS North America Corporation
Gastroenterology & Urology · 27d
Cleared May 12, 2015
syngo.CT Lung CAD
K143196 · OEB
Siemens AG Medical Solutions
Radiology · 187d
Cleared May 12, 2015
Venus Viva SR Device
K150161 · GEI
Venus Concept , Ltd.
General & Plastic Surgery · 109d
Cleared May 12, 2015
Mont Blanc Spinal System
K150185 · NKB
Spineway
Orthopedic · 105d
Cleared May 12, 2015
BLUE VINYL GLOVES POWDER FREE
K150224 · LYZ
Zibo Sanying Trade Co., Ltd.
General Hospital · 99d
Cleared May 12, 2015
Miromatrix Biological Mesh RS
K150341 · OXH
Miromatrix Medical, Inc.
General & Plastic Surgery · 90d
Cleared May 12, 2015
OASYS System
K150539 · NKG
Stryker Corporation
Orthopedic · 70d
Cleared May 12, 2015
Dorsal Spanning Plate
K150675 · HRS
Skeletal Dynamics, LLC
Orthopedic · 57d
Cleared May 12, 2015
GEMORE OTC TENS
K150681 · NUH
Gemore Technology Co, Ltd.
Neurology · 56d
Cleared May 12, 2015
Coda LP Balloon Catheter
K150970 · DQY
Cook Incorporated
Cardiovascular · 29d
Cleared May 11, 2015
GYMFORM ABS & CORE
K142055 · NGX
Well Brain International , Ltd.
Physical Medicine · 286d
Cleared May 11, 2015
NobelActive
K142260 · DZE
Nobel Biocare AB
Dental · 270d