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
32617–32640 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 2016
Thora-3Di, Model T-01
K151940 · BZQ
Pneumacare Limited
Anesthesiology · 240d
Cleared Mar 10, 2016
Thommen Milling Abutment for CAD/CAM
K151984 · NHA
Thommen Medical AG
Dental · 237d
Cleared Mar 10, 2016
Exactech Vantage Total Ankle System
K152217 · HSN
Exactech, Inc.
Orthopedic · 216d
Cleared Mar 10, 2016
Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color
K152720 · LZA
Xingda Medical Products Co., Ltd.
General Hospital · 171d
Cleared Mar 10, 2016
OMNI Skirted Heads
K152919 · LZO
Omni Life Science, Inc.
Orthopedic · 160d
Cleared Mar 10, 2016
Reprocessed Diagnostic Ultrasound Catheter
K153090 · OWQ
Innovative Health, LLC
Cardiovascular · 136d
Cleared Mar 10, 2016
PEEK Customized Cranial Implant
K153248 · GWO
Stryker
Neurology · 122d
Cleared Mar 10, 2016
ENROUTE Transcarotid Neuroprotection System
K153485 · NTE
Silk Road Medical, Inc.
Cardiovascular · 98d
Cleared Mar 10, 2016
Optetrak One Logic Femoral Components
K153776 · MBH
Exactech, Inc.
Orthopedic · 70d
Cleared Mar 10, 2016
Sonoma Fibula Repair System
K160069 · HSB
Sonoma Orthopedics Products, Inc.
Orthopedic · 57d
Cleared Mar 10, 2016
Vivid T8
K160078 · IYN
Ge Medical Systems Ultrasound and...
Radiology · 56d
Cleared Mar 10, 2016
GuideWire
K160369 · PGW
Fiagon GmbH
Ear, Nose, Throat · 29d
Cleared Mar 10, 2016
ReadeR, VieweR, QuickScan PSP
K160386 · MUH
Trident S.R.L
Radiology · 28d
Cleared Mar 09, 2016
Gammex PI Hybrid Surgical Gloves
K151694 · KGO
Ansell Healthcare Products, LLC
General Hospital · 260d
Cleared Mar 09, 2016
da Vinci Single-Site Instrument and Accessories
K152448 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 195d
Cleared Mar 09, 2016
MMS Guide Catheter
K152625 · KRA
Micro Medical Solutions, Inc.
Cardiovascular · 176d
Cleared Mar 09, 2016
S-Wire
K152662 · HTY
Spinal Resources, Inc.
Orthopedic · 174d
Cleared Mar 09, 2016
Nitrile Powder Free Patient Examination Gloves, Blue Color
K152712 · LZA
Zhonghong Pulin Medical Products Co.,...
General Hospital · 170d
Cleared Mar 09, 2016
SmartView 3D Option
K153429 · JAK
Ge Hangwei Medical System Co., Ltd.
Radiology · 105d
Cleared Mar 09, 2016
Family of CoolGlide Aesthetic Lasers
K153671 · GEX
Cutera, Inc.
General & Plastic Surgery · 79d
Cleared Mar 09, 2016
Piccolo Composite(R) Distal Volar Radius Plate System
K160002 · HRS
CarboFix Orthopedics , Ltd.
Orthopedic · 65d
Cleared Mar 09, 2016
Biomet Variable Pitch Compression Screw System
K160058 · HWC
Biomet, Inc.
Orthopedic · 57d
Cleared Mar 09, 2016
TE7 Diagnostic Ultrasound System
K160381 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 28d
Cleared Mar 08, 2016
SurgiPure XD Reconstructive Tissue Matrix
K152206 · FTM
Tissue Regenix Group Plc
General & Plastic Surgery · 215d