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
30745–30768 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 2016
T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System
K162358 · MAX
Synthes USA Products, LLC
Orthopedic · 70d
Cleared Nov 01, 2016
13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter...
K162453 · NDN
Pan Medical , Ltd.
Orthopedic · 61d
Cleared Oct 31, 2016
Disposable Pressure Transducer
K152472 · DRS
Zhejiang Haisheng Medical Device Co.,...
Cardiovascular · 427d
Cleared CT Oct 31, 2016
miraDry System
K160141 · NEY
Miramar Labs, Inc.
General & Plastic Surgery · 284d
Cleared Oct 31, 2016
Pleurx Pleural Catheter System
K160450 · DWM
Care Fusion
Anesthesiology · 256d
Cleared Oct 31, 2016
Footmotion Plating System
K161448 · HRS
Newclip Technics
Orthopedic · 159d
Cleared Oct 31, 2016
Unger Quad Injector
K161483 · LCJ
Stradis Healthcare
General & Plastic Surgery · 153d
Cleared Oct 31, 2016
Glass Ionomer Cement (Luting)
K161851 · EMA
Shandong Huge Dental Material...
Dental · 117d
Cleared Oct 31, 2016
BreathID Hp Lab System
K162150 · MSQ
Exalenz Bioscience , Ltd.
Microbiology · 90d
Cleared Oct 31, 2016
AxoGuard Nerve Connector
K162741 · JXI
Cook Biotech Incorporated
Neurology · 31d
Cleared Oct 31, 2016
Squirt Fluid Delivery System
K162777 · QEY
Merit Medical Systems, Inc.
Cardiovascular · 28d
Cleared Oct 30, 2016
FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W,...
K161282 · GXY
Medico Electrodes International , Ltd.
Neurology · 177d
Cleared Oct 28, 2016
Xonrid Gel
K152533 · FRO
Helsinn Healthcare SA
General & Plastic Surgery · 421d
Cleared Oct 28, 2016
ClearVision ExamVue Flat Panel Detector
K160143 · MQB
Jpi Healthcare, Inc.
Radiology · 281d
Cleared Oct 28, 2016
Tuohy NRFit
K160297 · BSP
PAJUNK GmbH Medizintechnologie
Anesthesiology · 268d
Cleared Oct 28, 2016
FRAXIS DUO
K160312 · GEX
Ilooda Co,., Ltd.
General & Plastic Surgery · 266d
Cleared CT Oct 28, 2016
Cutera enlighten III Laser System
K160488 · GEX
Cutera, Inc.
General & Plastic Surgery · 249d
Cleared Oct 28, 2016
Link Abutment for CEREC
K160519 · NHA
Osstem Implant Co., Ltd.
Dental · 246d
Cleared Oct 28, 2016
PaX-i3D Green Premium (Model: PCT-90LH)
K160882 · OAS
VATECH Co., Ltd.
Radiology · 211d
Cleared Oct 28, 2016
Gammex Cut-Resistant Glove Liner
K160974 · KGO
Ansell Healthcare Products, LLC
General Hospital · 204d
Cleared Oct 28, 2016
Dental Implants and Abutments
K161497 · DZE
Ditron Precision, Ltd.
Dental · 149d
Cleared Oct 28, 2016
ELEOS Limb Salvage System
K161520 · KRO
Onkos Surgical, Inc.
Orthopedic · 148d
Cleared Oct 28, 2016
Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing...
K161725 · HGX
Medela, Inc.
Obstetrics & Gynecology · 128d
Cleared Oct 28, 2016
FIREFLY® Pedicle Screw Navigation Guide
K162419 · PQC
Mighty Oak Medical, Inc.
Orthopedic · 59d