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
40489–40512 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 2013
JUSHA-M32 MEDICAL DISPLAY
K131391 · LLZ
Nanjing Jusha Display Technology Co.,...
Radiology · 99d
Cleared Aug 21, 2013
IMDX FLU A/B AND RSV FOR ABBOTT M2000
K131584 · OCC
Intelligent Medical Devices, Inc.
Microbiology · 82d
Cleared Aug 21, 2013
3DVH
K131862 · IYE
Sun Nuclear Corporation
Radiology · 58d
Cleared Aug 21, 2013
EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
K132304 · IYN
Philips Ultrasound, Inc.
Radiology · 28d
Cleared Aug 20, 2013
KIMGUARD ONE STEP STERILIZATION WRAP
K113806 · FRG
Kimberly-Clark Health Care
General Hospital · 606d
Cleared Aug 20, 2013
THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
K122766 · OUF
Microgenics Corp.
Chemistry · 344d
Cleared Aug 20, 2013
LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM
K123563 · DOF
Magellan Diagnostics
Chemistry · 274d
Cleared Aug 20, 2013
MULTILINK HYBRID ABUTMENT CEMENT
K130436 · EMA
Ivoclar Vivadent, AG
Dental · 180d
Cleared Aug 20, 2013
SYNGO.MR GENERAL
K130749 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 154d
Cleared Aug 20, 2013
SURESUBTRACTION ORTHO
K130960 · JAK
Toshibamedical Systems Corporation
Radiology · 137d
Cleared Aug 20, 2013
STAXX IBL SYSTEM
K131071 · MAX
Spine Wave, Inc.
Orthopedic · 125d
Cleared Aug 20, 2013
CAS PSI SHOULDER
K131129 · KWS
Zimmer Cas
Orthopedic · 120d
Cleared Aug 20, 2013
KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE
K131254 · BTR
Kimberly-Clark Corp.
Anesthesiology · 110d
Cleared Aug 20, 2013
MAPCHECK2, ARCCHECK
K131466 · IYE
Sun Nuclear Corporation
Radiology · 91d
Cleared Aug 20, 2013
PAGODA PEDICLE SCREW SYSTEM
K131785 · NKB
Ortho Development Corp.
Orthopedic · 63d
Cleared Aug 20, 2013
GUARDIAN URETHRAL SHEATH
K131803 · KNY
Solace Therapeutics
Gastroenterology & Urology · 62d
Cleared Aug 20, 2013
STERICAN CANNULA
K131842 · FMI
B.Braun Medical, Inc.
General Hospital · 60d
Cleared Aug 20, 2013
UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM
K132228 · IYO
Samsung Medison Co., Ltd.
Radiology · 34d
Cleared Aug 20, 2013
SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION
K132365 · MNI
Accel Spine
Orthopedic · 21d
Cleared Aug 19, 2013
ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT...
K131488 · CIX
Alfa Wassermann Diagnostics...
Chemistry · 88d
Cleared Aug 19, 2013
AXERA 2 ACCESS SYSTEM
K132263 · DYB
Arstasis, Inc.
Cardiovascular · 28d
Cleared Aug 16, 2013
PERF-GEN PULSATILE PERFUSION SOLUTION
K121736 · KDL
Waters Medical Systems, LLC
Gastroenterology & Urology · 429d
Cleared Aug 16, 2013
ENDO A CLASS
K123582 · EKX
Saeyang Microtech Co., Ltd.
Dental · 269d
Cleared Aug 16, 2013
ABG III MONOLITHIC HIP STEM
K123604 · MAY
Howmedica Osteonics Corp.
Orthopedic · 268d