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
137377–137400 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 1988
PTI HEART-CHILL POUCH/PAD SLING (STERILE)
K873924 · DWC
Buckman Co., Inc.
Cardiovascular · 130d
Cleared Feb 02, 1988
MEDTRONIC MODEL 4016A ENDOCARDIAL PACING LEAD
K873962 · DTB
Medtronic Vascular
Cardiovascular · 126d
Cleared Feb 02, 1988
BETA-HCG ASSAY
K873986 · DHA
Schiff & Co.
Chemistry · 126d
Cleared Feb 02, 1988
MODIFIED CALCITONIN RIA KIT DSL #1200
K874087 · JKR
Diagnostic Systems Laboratories, Inc.
Chemistry · 118d
Cleared Feb 02, 1988
ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T
K874205 · DTB
Pacesetter Systems
Cardiovascular · 110d
Cleared Feb 02, 1988
QUANTIMETRIX TOTAL CREATINE KINASE CONTROL
K874302 · JJT
Quantimetrix Medical Industries
Chemistry · 105d
Cleared Feb 02, 1988
HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR
K874605 · KRI
Mallinckrodt Critical Care
Cardiovascular · 85d
Cleared Feb 02, 1988
STERILIZATION OF DEVICES BY RADIATION
K874659 · BTT
Inhalation Plastics
Anesthesiology · 105d
Cleared Feb 02, 1988
PULSEMATE BX-5
K874692 · DQA
Colin Medical Instruments Corp.
Anesthesiology · 78d
Cleared Feb 02, 1988
GAMOW HYPERBARIC BAG
K874752 · CBF
Hyperbaric Aerobics, Ltd.
Anesthesiology · 76d
Cleared Feb 02, 1988
STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III
K874757 · DIF
Baxter Healthcare Corp
Toxicology · 76d
Cleared Feb 02, 1988
INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER
K874841 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 70d
Cleared Feb 02, 1988
CATR(TM)-H CARDIOTOMY HOLDER
K874867 · KPI
Bentley Laboratories, Inc.
Gastroenterology & Urology · 67d
Cleared Feb 02, 1988
SARNS VISIFLOW AORTIC ARCH CANNULA
K874896 · DWF
3M Health Care, Sarns
Cardiovascular · 63d
Cleared Feb 02, 1988
SCHURMAN/CARTER II HIP PROSTHESIS, POROUS COATED
K874939 · DXQ
Kirschner Medical Corp.
Cardiovascular · 62d
Cleared Feb 02, 1988
FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS
K874962 · HAO
Solway, Inc.
Neurology · 62d
Cleared Feb 02, 1988
SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE
K875104 · LLO
Laserguide
Anesthesiology · 46d
Cleared Feb 02, 1988
WAKO(TM) UIBC
K875176 · JQF
Wako Chemicals USA, Inc.
Chemistry · 47d
Cleared Feb 02, 1988
LACTATE DEHYDROGENASE CAT. # 320-68, 320-69
K875206 · CFJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 46d
Cleared Feb 02, 1988
ALKALINE PHOSPHATASE CAT. # 306-22, 306-23
K875210 · CJE
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 46d
Cleared Feb 02, 1988
V-TREND BETA-HCG DRY-SPOT TEST
K875262 · JHJ
Texas Immunology, Inc.
Chemistry · 42d
Cleared Feb 02, 1988
BIOTROL CALIBRANT LEVEL 1
K875288 · JIX
Biotrol, USA, Inc.
Chemistry · 35d
Cleared Feb 02, 1988
BIOTROL CALIBRANT LEVEL 3
K875318 · JIX
Biotrol, USA, Inc.
Chemistry · 35d
Cleared Feb 01, 1988
KONTRON E.E.G. MONITOR, SUPERMON MODULE 7265
K870815 · GWQ
Kontron Instruments, Inc.
Neurology · 335d