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
44593–44616 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 20, 2012
MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM)...
K120868 · DSP
Datascope Corp., Cardiac Assist Division
Cardiovascular · 29d
Cleared Apr 20, 2012
ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH...
K120872 · FPA
Unomedical A/S Infusion Devices
General Hospital · 29d
Cleared Apr 20, 2012
PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR...
K120942 · MBI
Parcus Medical, LLC
Orthopedic · 22d
Cleared Apr 19, 2012
PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES
K111464 · LZA
Dipped Products (Thailand), Ltd.
General Hospital · 329d
Cleared Apr 19, 2012
VIRTUOSO SYSTEM FOR IHC P53 (DO-7)
K111872 · NQN
Ventana Medical Systems, Inc.
Pathology · 293d
Cleared Apr 19, 2012
NOVAC 11
K112286 · IYE
New Radiant Technology S.P.A.
Radiology · 254d
Cleared Apr 19, 2012
SONICISION STERILIZATION TRAY
K112536 · KCT
Covidien
General Hospital · 231d
Cleared Apr 19, 2012
PULSE OXIMETER
K112843 · DQA
Nonin Medical, Inc.
Anesthesiology · 203d
Cleared Apr 19, 2012
NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA
K113494 · GAW
Nobles Medical Technologies Ii, Inc.
General & Plastic Surgery · 146d
Cleared Apr 19, 2012
MODULAR PROXIMALLY FLUTED HIP STEM
K113789 · MEH
Smith & Nephew, Inc.
Orthopedic · 119d
Cleared Apr 19, 2012
PRIMUS HEARING INSTRUMENT TEST UNIT
K113831 · ETW
Auditdata A/S
Ear, Nose, Throat · 114d
Cleared Apr 19, 2012
VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K120063 · MAX
L & K Biomed Co., Ltd.
Orthopedic · 101d
Cleared Apr 19, 2012
RESOLUTIONMD WEB
K120076 · LLZ
Calgary Scientific, Inc.
Radiology · 100d
Cleared Apr 19, 2012
NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES
K120182 · KNT
Neomed, Inc.
Gastroenterology & Urology · 90d
Cleared Apr 19, 2012
OLEA SPHERE
K120196 · LLZ
Olea Medical
Radiology · 87d
Cleared Apr 19, 2012
GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
K120201 · IYO
Ge Vingmed Ultrasound AS
Radiology · 87d
Cleared Apr 19, 2012
EZONO 3000
K120234 · IYN
Life-Tech, Inc.
Radiology · 85d
Cleared Apr 19, 2012
PHILIPS MICRODOSE
K120255 · MUE
Philips Digital Mammography Sweden AB
Radiology · 83d
Cleared Apr 19, 2012
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K120316 · JWH
Conformis, Inc.
Orthopedic · 78d
Cleared Apr 19, 2012
2MP MONOCHROME LCD MONITOR, RADIFORCE GX240
K120407 · LLZ
Eizo Nanao Corporation
Radiology · 70d
Cleared Apr 19, 2012
DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM
K120699 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 43d
Cleared Apr 19, 2012
INSTAPACS/INSTARISPACS
K120718 · LLZ
Meddiff Technologies Pvt. , Ltd.
Radiology · 42d
Cleared Apr 19, 2012
RIVAL PTA DILATATION CATHETER
K120722 · LIT
Bard Peripheral Vascular, Inc.
Cardiovascular · 41d
Cleared Apr 19, 2012
OTIS-C PLUS
K120818 · HRS
Science For Biomaterials
Orthopedic · 31d