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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
64153–64176 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 2005
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL...
K052887 · FPA
Terumo Europe N.V.
General Hospital · 56d
Cleared Dec 08, 2005
MPS ACACIA NERVE BLOCK NEEDLE
K052946 · CAZ
Mps Acacia
Anesthesiology · 49d
Cleared Dec 08, 2005
NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5
K053129 · FPA
Nexus Medical, LLC
General Hospital · 30d
Cleared Dec 08, 2005
BIOPURE MTAD ROOT CANAL CLEANSER
K053167 · KJJ
Dentsply Intl., Inc.
Dental · 24d
Cleared Dec 08, 2005
AMEDITECH DRUGSMARTCUP
K053175 · DKZ
Ameditech, Inc.
Toxicology · 24d
Cleared Dec 07, 2005
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
K051513 · DYB
Bipore, Inc.
Cardiovascular · 188d
Cleared Dec 07, 2005
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
K051693 · GKL
Bayer Healthcare, LLC
Hematology · 167d
Cleared Dec 07, 2005
TOTAL BILE ACIDS ASSAY, MODEL DZ042A
K051714 · KWW
Diazyme Laboratories
Chemistry · 163d
Cleared Dec 07, 2005
ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL
K051733 · NHG
Drg Intl., Inc.
Chemistry · 162d
Cleared Dec 07, 2005
SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100
K052108 · NBW
Sein Electronics Co., Ltd.
Chemistry · 126d
Cleared Dec 07, 2005
SYNTHES PANGEA MONOAXIAL SYSTEM
K052151 · NKB
Synthes Spine Co.Lp
Orthopedic · 121d
Cleared Dec 07, 2005
UTOPIA
K052249 · BZD
Respcare, Inc.
Anesthesiology · 111d
Cleared Dec 07, 2005
SMITH & NEPHEW PLATFORM HIP STEM
K052275 · LZO
Smith & Nephew, Inc.
Orthopedic · 107d
Cleared Dec 07, 2005
E-SAN BLUETOOTH CRADLE
K052343 · NBW
E-San Limited
Chemistry · 103d
Cleared Dec 07, 2005
MESA SPINAL SYSTEM
K052398 · MNI
K2m, LLC
Orthopedic · 98d
Cleared Dec 07, 2005
SMITH & NEPHEW MODULAR HIP
K052426 · MEH
Smith & Nephew, Inc.
Orthopedic · 96d
Cleared Dec 07, 2005
EXTENDSURE HBFASC CONTROL
K053031 · JCM
Cantebury Scientific , Ltd.
Hematology · 41d
Cleared Dec 07, 2005
KALIX II IMPLANT, MODEL 141 0XX WITH XX
K053093 · HWC
New Deal, S.A.
Orthopedic · 34d
Cleared Dec 07, 2005
DISTAL RADIO-ULNAR JOINT IMPLANT
K053119 · KXE
Aptis Medical, LLC
Orthopedic · 30d
Cleared Dec 07, 2005
MICRUS MODIFIED MICROCOIL 18-SYSTEM, CERECYTE, MODEL CSP & CHE
K053160 · HCG
Micrus Endovascular Corporation
Neurology · 23d
Cleared Dec 07, 2005
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
K053200 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 21d
Cleared Dec 07, 2005
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K053202 · FTL
W.L. Gore & Associates
General & Plastic Surgery · 21d
Cleared Dec 07, 2005
EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE)
K053281 · LLZ
Emageon, Inc.
Radiology · 12d
Cleared Dec 07, 2005
MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY)
K053325 · IYO
Mediwatch, Ltd.
Radiology · 6d