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
59521–59544 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 24, 2007
MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR
K071014 · FRC
Advanced Sterilization Products
General Hospital · 44d
Cleared May 24, 2007
TEXIUM SYRINGE
K071108 · FMF
Cardinal Health, Alaris Products
General Hospital · 35d
Cleared May 24, 2007
ANTLIA I WOUND IRRIGATION SYSTEM
K071301 · OMP
Innovative Therapies, Inc.
General & Plastic Surgery · 15d
Cleared May 24, 2007
SMARTSPONGE SYSTEM
K071355 · LWH
Clearcount Medical Solutions, Inc.
General & Plastic Surgery · 9d
Cleared May 23, 2007
MODIFICATION TO RELIADENT DENTAL IMPLANT SYSTEM
K061323 · DZE
Bioinfera, Inc.
Dental · 377d
Cleared May 23, 2007
5MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2010-5NC
K063269 · LLZ
Chi Lin Technology Co., Ltd.
Radiology · 205d
Cleared May 23, 2007
45L CORE INSUFFLATOR, MODEL F114
K063367 · HIF
W.O.M. World of Medicine AG
Obstetrics & Gynecology · 197d
Cleared May 23, 2007
STRYKER INTRADISCAL RF GENERATOR
K063489 · GXD
Synergetics, Inc.
Neurology · 187d
Cleared May 23, 2007
SALINE/ CONTRAST MEDIA INFUSION CATHETER
K063611 · LKF
Utah Medical Products, Inc.
Obstetrics & Gynecology · 171d
Cleared May 23, 2007
ICARE TONOMETER TA01I
K063873 · HKY
Tiolat OY
Ophthalmic · 145d
Cleared May 23, 2007
VITALITY HIP SYSTEM MODEL#420
K070050 · LPH
Encore Medical, L.P.
Orthopedic · 139d
Cleared May 23, 2007
POWER PORT-A-CATH AND POWER PORT-A-CATH II
K070116 · LJT
Smiths Medical MD, Inc.
General Hospital · 131d
Cleared May 23, 2007
GASTROSTOMY REPLACEMENT TUBE, MODEL 253
K070124 · KNT
Degania Silicone , Ltd.
Gastroenterology & Urology · 127d
Cleared May 23, 2007
BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX
K070473 · DXN
Zen Strong Medical Technology Co., Ltd.
Cardiovascular · 92d
Cleared May 23, 2007
MP 719
K070557 · FRO
Marine Polymer Technologies, Inc.
General & Plastic Surgery · 85d
Cleared May 23, 2007
CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES
K070807 · GXY
Pepin Mfg., Inc.
Neurology · 58d
Cleared May 23, 2007
MODIFICATION TO SENTINEL CLIN CHEM CAL
K070971 · JIX
Sentinel Ch. Srl
Chemistry · 47d
Cleared May 23, 2007
DEPUY CI HIP INSTRUMENTATION
K071135 · HAW
DePuy Orthopaedics, Inc.
Neurology · 30d
Cleared May 23, 2007
METAL HEMI IMPLANT
K071243 · KWD
Orthopro, LLC
Orthopedic · 20d
Cleared May 22, 2007
AOS MARKER SEEDS
K062825 · KXK
Alpha-Omega Services, Inc.
Radiology · 244d
Cleared May 22, 2007
AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS
K062826 · JAQ
Alpha-Omega Services, Inc.
Radiology · 244d
Cleared May 22, 2007
STRYKER RF INTRADISCAL ADAPTOR, MODEL 406-750
K063480 · GEI
Stryker Corp.
General & Plastic Surgery · 186d
Cleared May 22, 2007
AMYLASE EPS REAGENT
K070064 · JFJ
Thermo Fisher Scientific
Chemistry · 137d
Cleared May 22, 2007
JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS
K070234 · MPB
Jms North America Corp.
Gastroenterology & Urology · 126d