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
146161–146184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 1986
NAVIGATOR
K853747 · DTB
Mainsfield Scientific, Inc.
Cardiovascular · 121d
Cleared Jan 08, 1986
CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH
K854113 · KRI
American Bentley
Cardiovascular · 92d
Cleared Jan 08, 1986
BIO MEDICUS BIO CONSOLE 540
K854133 · DWA
Bio Medicus, Inc.
Cardiovascular · 90d
Cleared Jan 08, 1986
CMI 3000
K854233 · DRO
Cardio Management, Inc.
Cardiovascular · 79d
Cleared Jan 08, 1986
SEPACELL R-500 & SEPACELL R-500A
K854259 · CAK
Advocacy International, Ltd.
General Hospital · 77d
Cleared Jan 08, 1986
PREVIEW XT
K854282 · DSI
Cambridge Medical Instruments, Inc.
Cardiovascular · 76d
Cleared Jan 08, 1986
GEM-6, WITH COMPONENTS
K854357 · DRY
Diamond Electro-Tech, Inc.
Cardiovascular · 71d
Cleared Jan 08, 1986
HEMODIALYSIS CONCENTRATE
K854391 · FKQ
Dana Laboratories
Gastroenterology & Urology · 69d
Cleared Jan 08, 1986
HEMOSTATIC SIDEARM
K854397 · DTL
Target Therapeutics
Cardiovascular · 69d
Cleared Jan 08, 1986
O'NEIL URINARY CATHETER INTRODUCER
K854443 · KOD
Pennine Medical , Ltd.
Gastroenterology & Urology · 64d
Cleared Jan 08, 1986
ANALYST PHYSICIAN'S OFFICE PROFILER
K854523 · JJG
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 57d
Cleared Jan 08, 1986
PLUME Y SET
K854951 · FIE
Hospal Medical Corp.
Gastroenterology & Urology · 29d
Cleared Jan 08, 1986
COLOSHIELD KIT
K855121 · KNT
Deknatel, Inc.
Gastroenterology & Urology · 16d
Cleared Jan 07, 1986
DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES
K853038 · DRX
Bio-Detek, Inc.
Cardiovascular · 172d
Cleared Jan 07, 1986
ISOTRAK AMYLASE TEST AMYLASE ISOENZYME
K853951 · CIJ
Behring Diagnostics, Inc.
Chemistry · 104d
Cleared Jan 07, 1986
CD-100 CARDIAC MONITOR
K854041 · DRT
Cardio Display Corp.
Cardiovascular · 97d
Cleared Jan 07, 1986
PROGRAMALITH III MODELS 238 & 239
K854195 · DXY
Pacesetter Systems
Cardiovascular · 84d
Cleared Jan 07, 1986
MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT
K854379 · JLW
Bioclinical Systems, Inc.
Chemistry · 69d
Cleared Jan 07, 1986
MICROSAMPLE COAGULATION ANALYSER MODEL 110P
K854546 · JPA
Bio/Data Corp.
Hematology · 55d
Cleared Jan 07, 1986
NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909
K854716 · CIC
Nobel Scientific Industries, Inc.
Chemistry · 46d
Cleared Jan 07, 1986
LEE-BEAD BETA LH (EIA)
K854838 · CEP
Leeco Diagnostics, Inc.
Chemistry · 35d
Cleared Jan 07, 1986
CRITIC - SF, ASSAYED
K854967 · JJY
Dimension Diagnostics
Chemistry · 27d
Cleared Jan 07, 1986
CLEARENE, CLEARING AGENT
K855109 · KEM
Surgipath Medical Industries, Inc.
Pathology · 15d
Cleared Jan 07, 1986
DRI-FORM UREAPLASMA DIFFERENTIAL BASAL AGAR MED.A8
K855110 · JSI
Gibco Laboratories Life Technologies,...
Microbiology · 15d