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
35497–35520 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 2015
FlexiMarc Marker
K142294 · IYE
Cortex Manufacturing, Inc.
Radiology · 220d
Cleared Mar 26, 2015
Headway 27 Microcatheter
K142449 · DQY
MicroVention, Inc.
Cardiovascular · 205d
Cleared Mar 26, 2015
PLIASURE Polyglycolide Synthetic Absorbable Suture
K142822 · GAM
Ethicon, Inc.
General & Plastic Surgery · 177d
Cleared Mar 26, 2015
Nellcor Bedside SpO2 Patient Monitoring System
K142865 · DQA
Covidien, LLC
Anesthesiology · 177d
Cleared Mar 26, 2015
Mammo Workstation
K143361 · LLZ
Ge Healthcare
Radiology · 122d
Cleared Mar 26, 2015
SOMATOM Definition AS Open (VA48)
K143409 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 118d
Cleared Mar 26, 2015
TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO...
K150052 · NBW
Nipro Diagnostics, Inc.
Chemistry · 73d
Cleared Mar 26, 2015
DD cubeX2
K150196 · EIH
Dental Direkt GmbH
Dental · 56d
Cleared Mar 26, 2015
A35 Diagnostic Ultrasound System
K150478 · IYN
Samsung Medison Co., Ltd.
Radiology · 30d
Cleared Mar 26, 2015
AVERT Contrast Modulation System
K150485 · DXT
Osprey Medical, Inc.
Cardiovascular · 30d
Cleared Mar 26, 2015
ER36 Series OAE Test System
K150491 · EWO
Etymotic Research, Inc.
Ear, Nose, Throat · 29d
Cleared Mar 25, 2015
DISPOSABLE ENDOSCOPIC CANNULA
K140213 · HGH
Dongguan Microview Medical Technology...
Obstetrics & Gynecology · 421d
Cleared Mar 25, 2015
GLOVE PORT
K141715 · GCJ
Nelis
General & Plastic Surgery · 273d
Cleared Mar 25, 2015
STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER,...
K141833 · HAW
Medtronic Navigation, Inc.
Neurology · 261d
Cleared Mar 25, 2015
INVISION TOTAL ANKLE REVISION SYSTEM
K142117 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 233d
Cleared Mar 25, 2015
Modified ONFLEX Mesh
K142706 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 184d
Cleared Mar 25, 2015
PASS LP Spinal System
K142798 · MNH
Medicrea International SA
Orthopedic · 177d
Cleared Mar 25, 2015
Powder-free Clear Vinyl Patient Examination Gloves
K142892 · LYZ
Shenyi (Shandong) Plastic Products...
General Hospital · 173d
Cleared Mar 25, 2015
Baha 5 Sound Processor
K142907 · LXB
Cochlear Americas
Ear, Nose, Throat · 170d
Cleared Mar 25, 2015
F5
K143014 · ITI
Permobil AB
Physical Medicine · 156d
Cleared Mar 25, 2015
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface,...
K143073 · DTZ
Medtronic, Inc.
Cardiovascular · 149d
Cleared Mar 25, 2015
Bio-Medicus Pediatric Cannula and Introducers
K143083 · DWF
Medtronic, Inc.
Cardiovascular · 149d
Cleared Mar 25, 2015
Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X
K143104 · EBF
Kettenbach GmbH & Co. KG
Dental · 147d
Cleared Mar 25, 2015
VEGA Knee System, Columbus Total Knee System
K143443 · JWH
Aesculap Implants Systems, LLC
Orthopedic · 113d