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
34417–34440 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 2015
SmartDrive Wheelchair Power Assist
K151199 · ITI
Max Mobility, LLC
Physical Medicine · 86d
Cleared Jul 30, 2015
Gemini XXP-HP
K151298 · LNS
Dornier Medtech America
Gastroenterology & Urology · 76d
Cleared Jul 30, 2015
5MP Monochrome LCD Monitor, RadiForce GX540
K151883 · PGY
Eizo Corporation
Radiology · 21d
Cleared Jul 30, 2015
Infinity ERCP Sampling Device
K151889 · FDX
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 20d
Cleared Jul 29, 2015
Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl...
K143277 · LYZ
Lifestyle Safety Products (Hui Zhou)...
General Hospital · 257d
Cleared Jul 29, 2015
LnK Posterior Cervical Fixation System
K143278 · KWP
L & K Biomed Co., Ltd.
Orthopedic · 257d
Cleared Jul 29, 2015
GenIQ
K143368 · LLZ
Ge Medical Systems, LLC
Radiology · 246d
Cleared Jul 29, 2015
Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter
K150107 · DQY
Micro Therapeutics Inc Dba Ev3...
Cardiovascular · 190d
Cleared Jul 29, 2015
Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony...
K150377 · GCJ
Sony Electronics, Inc.
General & Plastic Surgery · 166d
Cleared CT Jul 29, 2015
Cellfina System
K150505 · OUP
Ulthera, Inc.
General & Plastic Surgery · 154d
Cleared Jul 29, 2015
ECHELON Oval V 5.0 MRI System
K151015 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 104d
Cleared Jul 29, 2015
3D/5D Viewer
K151808 · LLZ
Samsung Medison Co., Ltd.
Radiology · 27d
Cleared Jul 29, 2015
Atlas SPEEDER Header/Neck
K151829 · MOS
Quality Electrodynamics, LLC
Radiology · 23d
Cleared Jul 28, 2015
Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification
K142829 · DYB
Cook Incorporated
Cardiovascular · 301d
Cleared Jul 28, 2015
Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3,...
K142855 · DKZ
Omega Laboratories, Inc.
Toxicology · 301d
Cleared Jul 28, 2015
Barrx Anorectal RFA Wand
K150251 · GEI
Covidien, LLC
General & Plastic Surgery · 175d
Cleared Jul 28, 2015
Tyber Medical Wedge System
K150394 · PLF
Tyber Medical, LLC
Orthopedic · 160d
Cleared Jul 28, 2015
Bard LubriGuard Foley Catheter
K150699 · EZL
C.R. Bard, Inc.
Gastroenterology & Urology · 132d
Cleared Jul 28, 2015
2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors
K150715 · MBI
Tornier, Inc.
Orthopedic · 131d
Cleared Jul 28, 2015
Hyper-C Anterior Cervical Plate System
K150759 · KWQ
Degen Medical
Orthopedic · 127d
Cleared Jul 28, 2015
QBit Series Diagnostic Ultrasound System
K150861 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 118d
Cleared Jul 28, 2015
Piccolo Composite Nailing System
K151010 · HSB
CarboFix Orthopedics , Ltd.
Orthopedic · 104d
Cleared Jul 28, 2015
Philips Self-Adhesive Electrodes
K151033 · GXY
Philips Consumer Lifestyle
Neurology · 102d
Cleared Jul 28, 2015
Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and...
K151105 · MAI
Smith & Nephew, Inc.
Orthopedic · 95d