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

Filters: Cleared only ×
176,076 results
58009–58032 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 2007
ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P...
K072115 · CGX
Horiba Abx
Chemistry · 121d
Cleared Nov 30, 2007
BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205
K072325 · MNW
Jawon Medical Co., Ltd.
Gastroenterology & Urology · 102d
Cleared Nov 30, 2007
SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200,...
K072783 · JKA
Smiths Medical Asd, Inc.
Chemistry · 60d
Cleared Nov 30, 2007
STRYKER STRI-SHIELD FLYTE TOGAS
K073017 · FYA
Stryker Instruments, Instruments Div.
General Hospital · 36d
Cleared Nov 30, 2007
INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S
K073100 · DYB
Oscor, Inc.
Cardiovascular · 28d
Cleared Nov 30, 2007
NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE
K073236 · MOS
Neocoil
Radiology · 14d
Cleared Nov 29, 2007
STERRAD 100NX STERILIZER
K071385 · MLR
Advanced Sterilization Products
General Hospital · 195d
Cleared Nov 29, 2007
CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH...
K072049 · DXN
Bmeye B.V.
Cardiovascular · 127d
Cleared Nov 29, 2007
RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25
K072194 · NLF
Renu Medical, Inc.
Anesthesiology · 114d
Cleared Nov 29, 2007
PM-7000 PATIENT MONITOR
K072346 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 100d
Cleared Nov 29, 2007
HABIB ENDOBLATE
K072383 · KNS
Emcision , Ltd.
Gastroenterology & Urology · 97d
Cleared Nov 29, 2007
MOBIL-O-GRAPH NG 24 H ABP-CONTROL
K072446 · DXN
I.E.M. GmbH
Cardiovascular · 91d
Cleared Nov 29, 2007
CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS
K072449 · DPS
Welch Allyn, Inc.
Cardiovascular · 90d
Cleared Nov 29, 2007
SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM
K072463 · JEY
Satyrne Medical
Dental · 90d
Cleared Nov 29, 2007
HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY
K072482 · MEG
Smiths Medical Asd, Inc.
General Hospital · 86d
Cleared Nov 29, 2007
TEPHAFLEX SURGICAL FILM
K072520 · FTL
Tepha, Inc.
General & Plastic Surgery · 83d
Cleared Nov 29, 2007
YG-125T AND YG-135T NASAL ADAPTER
K072843 · CCK
Nihon Kohden America, Inc.
Anesthesiology · 56d
Cleared Nov 29, 2007
PARI HYDRATE V
K072982 · BTT
Pari Innovative Manufacturers, Inc.
Anesthesiology · 37d
Cleared Nov 29, 2007
CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K073060 · MVN
Innova Vision, Inc.
Ophthalmic · 30d
Cleared Nov 29, 2007
CARESCAPE V100
K073203 · MHX
Ge Medical Systems Information...
Cardiovascular · 16d
Cleared Nov 29, 2007
SA-3000P
K073323 · JOM
Medicore Co., Ltd.
Cardiovascular · 2d
Cleared Nov 28, 2007
IMPLUS IMPLANT SYSTEM
K062931 · DZE
Leader Italia S.R.L.
Dental · 426d
Cleared Nov 28, 2007
ELUTIA COATED CLOSED SURGICAL WOUND DRAIN
K063245 · OEI
Bacterin International, Inc.
General & Plastic Surgery · 398d
Cleared Nov 28, 2007
NOVEON, MODEL LS1100-01-0968
K071815 · GEX
Nomir Medical Technologies, Inc.
General & Plastic Surgery · 149d