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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
146065–146088 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 15, 1986
MEDSURG POTT-COURNAND NEEDLE
K854293 · DRC
Medsurg Industries, Inc.
Cardiovascular · 82d
Cleared Jan 15, 1986
CUSHION-FLEX TM-CPAP FACE MASK
K854458 · BYE
Life Design Systems, Inc.
Anesthesiology · 70d
Cleared Jan 15, 1986
ACUSON AL558 TRANSDUCER
K854785 · ITX
Acuson Computed Sonography
Radiology · 47d
Cleared Jan 15, 1986
ACUSON BL538 TRANSDUCER
K854786 · ITX
Acuson Computed Sonography
Radiology · 47d
Cleared Jan 15, 1986
ACUSON AL538 TRANSDUCER
K854788 · ITX
Acuson Computed Sonography
Radiology · 47d
Cleared Jan 15, 1986
T-4 RIASSAY
K854798 · CDX
Ria Diagnostics
Chemistry · 44d
Cleared Jan 15, 1986
ELECATH PULSATILE PERFUSION PUMP
K854975 · KFM
Electro-Catheter Corp.
Cardiovascular · 34d
Cleared Jan 14, 1986
MODEL TT-185 TELEMETRY TRANSMITTER
K851624 · DXH
Eaton Medical Group
Cardiovascular · 271d
Cleared Jan 14, 1986
CORDIS MULTICOR ST, MODEL 350A
K851968 · DXY
Cordis Corp.
Cardiovascular · 252d
Cleared Jan 14, 1986
CONFIDENT ODOR ELIMINATOR
K852471 · EXB
Hallmark Industries, Inc.
Gastroenterology & Urology · 217d
Cleared Jan 14, 1986
PALLADIUM SEED MODEL 100
K852542 · IWI
Nuclear Medicine, Inc.
Radiology · 214d
Cleared Jan 14, 1986
ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER
K852641 · DXY
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 208d
Cleared Jan 14, 1986
COMFORT - CUF
K852978 · DXN
Dynasty Instruments, Ltd.
Cardiovascular · 183d
Cleared Jan 14, 1986
OSM-1 OXYGEN SATURATION MONITOR
K853331 · JOM
Criticare Systems, Inc.
Cardiovascular · 159d
Cleared Jan 14, 1986
T4 MONITOR STIMULATOR COMPUTER
K853476 · BXN
Regional Master Corp.
Anesthesiology · 153d
Cleared Jan 14, 1986
NERVE FINDER
K853477 · BXN
Regional Master Corp.
Anesthesiology · 153d
Cleared Jan 14, 1986
THE BODYLOG 500 RET THERAPEUTIC ELECTROMYOGRAPHICS
K854208 · HCC
Bodylog, Inc.
Neurology · 89d
Cleared Jan 14, 1986
MODEL 2120 SPIROSCREEN
K854403 · BZG
Gould, Inc.
Anesthesiology · 75d
Cleared Jan 14, 1986
NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928
K854717 · CEK
Nobel Scientific Industries, Inc.
Chemistry · 53d
Cleared Jan 14, 1986
VISION SGOT (AST)
K854982 · CIT
Abbott Laboratories
Chemistry · 33d
Cleared Jan 14, 1986
AUTO SUTURE TITANIUM SURGICAL STAPLES
K855047 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 28d
Cleared Jan 14, 1986
GLUCOSE (UV HEXOKIASE) REAGENT SET
K855153 · CFR
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
INORGANIC PHOSPHORUS REAGENT SET
K855154 · CEO
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
GAMMA GLUTAMYL TRANSPEPTIDASE REAGENT SET
K855156 · JPZ
Technostics Intl.
Chemistry · 19d