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
45433–45456 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 2012
NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP...
K113410 · NHA
Straumann USA
Dental · 56d
Cleared Jan 13, 2012
OPTIMA MR450W
K113490 · LNH
Ge Medical Systems, LLC
Radiology · 51d
Cleared Jan 13, 2012
SCEPTER XC OCCLUSION BALLOON CATHETER
K113698 · MJN
MicroVention, Inc.
Cardiovascular · 28d
Cleared Jan 13, 2012
HEISENBERG EFFECT SHADES
K120011 · EIH
3M Espe AG
Dental · 10d
Cleared Jan 12, 2012
AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL...
K100437 · NBW
Bestgen Biotech Corp.
Chemistry · 694d
Cleared Jan 12, 2012
FUNNEL GUIDE CATHETER MODEL G1020608
K102439 · DQY
Lazarus Effect, Inc.
Cardiovascular · 504d
Cleared Jan 12, 2012
ABSOLUTE WHITE LIGHT
K110888 · EEG
Dr. Fresh, Inc.
Dental · 288d
Cleared Jan 12, 2012
CUROS PORT PROTECTOR
K111992 · QBP
Ivera Medical, Inc.
General Hospital · 183d
Cleared Jan 12, 2012
TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR
K113085 · DXN
Truly Instrument Co., Ltd.
Cardiovascular · 86d
Cleared Jan 12, 2012
OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM
K113123 · KTT
The Orthopaedic Implant Company
Orthopedic · 83d
Cleared Jan 12, 2012
ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM
K113318 · HRS
Acute Innovations, LLC
Orthopedic · 63d
Cleared Jan 12, 2012
CABLECAP
K113330 · FST
Sensormed
General & Plastic Surgery · 59d
Cleared Jan 12, 2012
CASPIAN
K113654 · KWP
K2m, Inc.
Orthopedic · 31d
Cleared Jan 12, 2012
CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING
K113667 · DTL
Edwards Lifesciences, LLC
Cardiovascular · 30d
Cleared Jan 12, 2012
LUCEA LED SURGICAL LIGHT SYSTEM
K113679 · NTN
Maquet S.A.S.
Gastroenterology & Urology · 29d
Cleared Jan 12, 2012
LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL
K113683 · FPA
Hospira, Inc.
General Hospital · 28d
Cleared Jan 12, 2012
TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED
K113699 · HEB
The Procter & Gamble Company
Obstetrics & Gynecology · 27d
Cleared Jan 11, 2012
REPROCESSED HARMONIC SCALPEL
K111794 · NLQ
Sterilmed, Inc.
General & Plastic Surgery · 198d
Cleared Jan 11, 2012
STERIS STEAM PI
K112256 · JOJ
STERIS Corporation
General Hospital · 159d
Cleared Jan 11, 2012
SANICLAVE 200
K112811 · FLE
Alternative Pioneering Research and...
General Hospital · 106d
Cleared Jan 11, 2012
COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY
K113069 · PHX
Biomet Manufacturing Corp
Orthopedic · 86d
Cleared Jan 11, 2012
SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM
K113405 · HRS
Suspension Orthopaedic Solutions, LLC
Orthopedic · 54d
Cleared Jan 11, 2012
SYNERGY TISSUE MATRIX
K113460 · FTM
Synovis Orthopedic & Woundcare
General & Plastic Surgery · 50d
Cleared Jan 11, 2012
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K113651 · KRD
Boston Scientific Corporation
Cardiovascular · 30d