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
57193–57216 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 07, 2008
CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY...
K072144 · MEA
Smiths Medical MD, Inc.
General Hospital · 218d
Cleared Mar 07, 2008
JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE
K072212 · KTT
Smith & Nephew, Inc.
Orthopedic · 211d
Cleared Mar 07, 2008
JET PORT PLUS HP CATHETER SYSTEM
K072481 · LJT
Pfm Medical, Inc.
General Hospital · 185d
Cleared Mar 07, 2008
CONVOY ADVANCED DELIVERY SHEATH
K072719 · DYB
Boston Scientific Corp
Cardiovascular · 164d
Cleared Mar 07, 2008
VENOWAVE MODELS VW5-6, VW5-10, VW5-20 AND VW5-30
K073028 · JOW
Venowave, Inc.
Cardiovascular · 133d
Cleared Mar 07, 2008
REPLUS DENTAL IMPLANTS (HA)
K073161 · DZE
Implant Direct, LLC
Dental · 119d
Cleared Mar 07, 2008
US/SS/GS SYSTEM
K073247 · DZE
Osstem Implant Co., Ltd.
Dental · 109d
Cleared Mar 07, 2008
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM
K073286 · JWH
Zimmer, Inc.
Orthopedic · 107d
Cleared Mar 07, 2008
CERTAIN CONTOURED MARGIN CERAMIC ABUTMENT
K073345 · NHA
Biomet 3i, Inc.
Dental · 100d
Cleared Mar 07, 2008
COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
K073374 · DTK
William Cook Europe Aps
Cardiovascular · 95d
Cleared Mar 07, 2008
COMPACT AUTO-SAFETY INJECTOR (CASI)
K073476 · KZH
Medical House (Asi) Limited
General Hospital · 88d
Cleared Mar 07, 2008
DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X
K073488 · MSJ
Diazyme Laboratories
Chemistry · 137d
Cleared Mar 07, 2008
LUMINEX LX 100/200 INSTRUMENT
K073506 · NSU
Luminex Corp.
Chemistry · 85d
Cleared Mar 07, 2008
CEMENTABLE ABUNTMENTS
K080286 · NHA
Straumann USA
Dental · 32d
Cleared Mar 07, 2008
ALMA LASER NIR MODULE
K080318 · ILY
Alma Lasers , Ltd.
Physical Medicine · 30d
Cleared Mar 07, 2008
HU II / HS II FIXTURE SYSTEM
K080387 · DZE
Osstem Implant Co., Ltd.
Dental · 23d
Cleared Mar 07, 2008
DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K080415 · DYB
Terumo Medical Corp.
Cardiovascular · 22d
Cleared Mar 06, 2008
LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM
K070800 · MOL
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 349d
Cleared Mar 06, 2008
DBEST ONE STEP OCCULT BLOOD TEST KITS
K071242 · KHE
Ameritek USA, Inc.
Hematology · 308d
Cleared Mar 06, 2008
HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5
K072163 · CAF
3A Health Care S.R.L.
Anesthesiology · 213d
Cleared Mar 06, 2008
PORTABLE VENTILATOR, MODEL EPV-100
K072214 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 210d
Cleared Mar 06, 2008
K-Y BRAND YOURS+MINE
K072421 · NUC
Mcneil-Ppc, Inc.
Obstetrics & Gynecology · 191d
Cleared Mar 06, 2008
APX21
K073185 · LQY
Techdent Technologies, Ltd.
Dental · 114d
Cleared Mar 06, 2008
ROCHE-CREACTIVE PROTEIN (LATEX)
K073277 · DCN
Roche Diagnostics Corp.
Immunology · 106d