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
37537–37560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 2014
COROENT XL-F SYSTEM
K140479 · OVD
Nu Vasive, Incorporated
Orthopedic · 152d
Cleared Jul 28, 2014
COROENT SMALL INTERBODY SYSTEM
K140921 · ODP
Nu Vasive, Incorporated
Orthopedic · 109d
Cleared Jul 28, 2014
KIMGUARD ONE-STEP STERILIZATION WRAP
K141071 · FRG
Kimberly-Clark Health Care
General Hospital · 94d
Cleared Jul 28, 2014
AQUARIUS EXTENSION FEEDING SET
K141631 · KNT
Degania Silicone , Ltd.
Gastroenterology & Urology · 40d
Cleared Jul 28, 2014
ACE CALIBRATOR
K141728 · JIT
SENTINEL CH. SpA
Chemistry · 32d
Cleared Jul 25, 2014
BNA ANALYSIS SYSTEM
K121119 · OLU
Eiminda , Ltd.
Neurology · 834d
Cleared Jul 25, 2014
HIVOX SELF ADHESIVE ELECTRODE GEL PADS
K131720 · GXY
Hivox Biotek, Inc.
Neurology · 408d
Cleared Jul 25, 2014
STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
K133444 · HAW
Medtronic Navigation, Inc.
Neurology · 255d
Cleared Jul 25, 2014
CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)
K133466 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 255d
Cleared Jul 25, 2014
CDI BLOOD PARAMETER MONITORING SYSTEM 500
K133658 · DRY
Terumo Cardiovascular Systems Corp.
Cardiovascular · 240d
Cleared Jul 25, 2014
BELTER BLOOD PRESSURE METER
K134029 · DXN
Shenzhen Belter Health Measurement...
Cardiovascular · 206d
Cleared Jul 25, 2014
3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE
K140250 · KKX
3M Healthcare
General Hospital · 175d
Cleared Jul 25, 2014
V-PRO STERILIZATION TRAY/ STERILIZATION MAT
K140494 · KCT
STERIS Corporation
General Hospital · 148d
Cleared Jul 25, 2014
ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS
K140553 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 143d
Cleared Jul 25, 2014
COCOON CONVECTIVE WARMING SYSTEM
K140635 · DWJ
Care Essentials Pty, Ltd.
Cardiovascular · 135d
Cleared Jul 25, 2014
MLX - MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM
K140770 · MAX
Nu Vasive, Incorporated
Orthopedic · 120d
Cleared Jul 25, 2014
ZQUIET-SA
K140777 · LRK
Sleeping Well, LLC
Dental · 119d
Cleared Jul 25, 2014
EDS COMBO-RINSE
K140846 · KJJ
Essential Dental Systems, Inc.
Dental · 113d
Cleared Jul 25, 2014
LIAISON XL ANALYZER
K141116 · LOL
DiaSorin, Inc.
Microbiology · 86d
Cleared Jul 25, 2014
MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER...
K141193 · PHC
Smiths Medical Asd, Inc.
General Hospital · 78d
Cleared Jul 25, 2014
0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH
K141311 · NGT
Becton, Dickinson and Company
General Hospital · 66d
Cleared Jul 25, 2014
HARD PACK SYRINGE
K141359 · FMF
Jiangyin Caina Technology Co., Ltd.
General Hospital · 63d
Cleared Jul 25, 2014
LS SERIES LINEAR STAPLER AND RELOADS, CLC SERIES CURVED LINEAR CUTTER AND...
K141367 · GDW
Touchstone International Medical...
General & Plastic Surgery · 63d
Cleared Jul 25, 2014
VOLUSON P6, VOLUSON P8
K141675 · IYN
Ge Healthcare
Radiology · 30d