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
65953–65976 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 2005
EZ-STIK ELECTRODES
K050469 · GXY
Naimco, Inc.
Neurology · 79d
Cleared May 13, 2005
QUANTIA A1-AT
K050596 · DEM
Biokit, S.A.
Immunology · 66d
Cleared May 13, 2005
BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7
K050680 · DXN
OSTAR MEDITECH CORP.
Cardiovascular · 58d
Cleared May 13, 2005
PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T...
K050717 · LPL
CooperVision, Inc.
Ophthalmic · 53d
Cleared May 13, 2005
EVERLIFE
K050788 · GXY
Everlife Medical Instrument Co., Ltd.
Neurology · 46d
Cleared May 13, 2005
RNA1C CONTROL FOR NYCOCARD HBA1C
K050961 · JJX
Bionostics, Inc.
Chemistry · 25d
Cleared May 13, 2005
FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
K051025 · JAA
Hologic, Inc.
Radiology · 21d
Cleared May 13, 2005
ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES
K051076 · MKJ
ZOLL Medical Corporation
Cardiovascular · 16d
Cleared May 13, 2005
X-CHANGE
K051090 · IOR
Meyra
Physical Medicine · 15d
Cleared May 13, 2005
ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM
K051139 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 9d
Cleared May 12, 2005
STERRAD NX CHALLENGE PACK
K042450 · FRC
Advanced Sterilization Products
General Hospital · 245d
Cleared May 12, 2005
RAPID ONE STEP BUPRENORPHINE TEST CARD
K042988 · DJG
Tianjin New Bay Bioresearch Co., Ltd.
Chemistry · 195d
Cleared May 12, 2005
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
K050471 · MNH
Solco Biomedical Co., Ltd.
Orthopedic · 78d
Cleared May 12, 2005
SINGLE USE ASPIRATION NEEDLE NA-201SX-4022
K050503 · FCG
Olympus Medical Systems Corporation
Gastroenterology & Urology · 73d
Cleared May 12, 2005
MINILOC SAFETY INFUSION SET
K050600 · FPA
Specialized Health Products, Intl.
General Hospital · 64d
Cleared May 12, 2005
FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
K050660 · HEB
First Quality Hygienic, Inc.
Obstetrics & Gynecology · 58d
Cleared May 12, 2005
QUANTA PLEX ANCA PROFILE
K050715 · MOB
Inova Diagnostics, Inc.
Immunology · 55d
Cleared May 12, 2005
ARTHREX TAK FAMILY
K050749 · HWC
Arthrex, Inc.
Orthopedic · 50d
Cleared May 12, 2005
BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML
K050780 · LON
Becton, Dickinson & CO
Microbiology · 45d
Cleared May 12, 2005
VITEK 2 GRAM POSITIVE MEROPENEM
K050816 · LON
bioMerieux, Inc.
Microbiology · 42d
Cleared May 12, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE (STREP) 0.0625 - 16...
K050881 · LON
Becton, Dickinson & CO
Microbiology · 35d
Cleared May 12, 2005
E.P.T. CERTAINTY PREGNANCY TEST
K050930 · LCX
Unipath , Ltd.
Chemistry · 28d
Cleared May 12, 2005
BASIS SPINAL SYSTEM
K051039 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 17d
Cleared May 12, 2005
BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
K051072 · GKA
Bio-Rad Laboratories, Inc.
Hematology · 16d