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
58705–58728 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 07, 2007
NES REPROCESSED ENDOSCOPIC TROCAR
K060676 · NLM
Northeast Scientific, Inc.
Gastroenterology & Urology · 542d
Cleared Sep 07, 2007
CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01
K062028 · NUA
Celera Diagnostics
Pathology · 416d
Cleared Sep 07, 2007
GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING...
K071118 · GXY
Ives Eeg Solutions, Inc.
Neurology · 140d
Cleared Sep 07, 2007
NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE
K071145 · MPB
Nipro Medical Corporation
Gastroenterology & Urology · 136d
Cleared Sep 07, 2007
ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A
K071255 · LCO
Hyphen Biomed
Hematology · 126d
Cleared Sep 07, 2007
EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM
K071348 · DQK
Mennen Medical , Ltd.
Cardiovascular · 116d
Cleared Sep 07, 2007
PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521
K071391 · MSX
Philips Medical Systems, Inc.
Cardiovascular · 112d
Cleared Sep 07, 2007
RELIANCE S.E.P.
K071688 · KLE
Reliance Orthodontic Products, Inc.
Dental · 79d
Cleared Sep 07, 2007
DEVILBISS INTELLIPAP MODEL DV 5 SERIES
K071689 · BZD
Sunrise Medical
Anesthesiology · 79d
Cleared Sep 07, 2007
AQUADEX FLEXFLOW SYSTEM
K071854 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 64d
Cleared Sep 07, 2007
CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR
K071911 · DQK
Innovision A/S
Cardiovascular · 58d
Cleared Sep 07, 2007
JUNIPER CLN1 DERMAL COOLING DEVICE
K072152 · ILO
Juniper Medical, Inc.
Physical Medicine · 35d
Cleared Sep 07, 2007
MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
K072208 · HBL
Integra LifeSciences Corporation
Neurology · 30d
Cleared Sep 07, 2007
SPY FLUORESCENT IMAGING SYSTEM
K072222 · IZI
Novadaq Technologies, Inc.
Radiology · 28d
Cleared Sep 07, 2007
GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL
K072232 · KDI
Gambro Renal Products, Inc.
Gastroenterology & Urology · 28d
Cleared Sep 07, 2007
HONEYWELL HOMMED CENTRAL STATION 4.0
K072272 · DXN
Honeywell Hommed, LLC
Cardiovascular · 23d
Cleared Sep 06, 2007
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K070282 · NKB
Endius, Inc.
Orthopedic · 220d
Cleared Sep 06, 2007
DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS
K071196 · DQO
Coeur, Inc.
Cardiovascular · 129d
Cleared Sep 06, 2007
SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12
K071221 · BTL
Automedx, Inc.
Anesthesiology · 127d
Cleared Sep 06, 2007
BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER
K071577 · HRS
Biomet Microfixation, Inc.
Orthopedic · 90d
Cleared Sep 06, 2007
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE...
K071910 · LZA
Hartalega Sdn Bhd
General Hospital · 57d
Cleared Sep 06, 2007
VECTEC DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES
K071976 · GEI
Vectec
General & Plastic Surgery · 51d
Cleared Sep 06, 2007
COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE
K072167 · DXC
Advanced Vascular Dynamics
Cardiovascular · 31d
Cleared Sep 06, 2007
NEXGEN PROLONG ALL-POLY PATELLA
K072281 · JWH
Zimmer, Inc.
Orthopedic · 21d