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
139849–139872 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 1987
LIQUID TDM CONTROLS
K871788 · DIF
Biological Industries
Chemistry · 42d
Cleared Jun 17, 1987
PATHO DX LATEX AGGLUTINATION STREP GROUPING KIT
K871831 · GTZ
Diagnostic Products Corp.
Microbiology · 37d
Cleared Jun 17, 1987
DIGITAL FEVER THERMOMETER MODEL MC-5
K871888 · FLL
Omron Electronics, Inc.
General Hospital · 34d
Cleared Jun 17, 1987
TECHNICON RA(R) SYSTEMS & ASSIST(R) CLIN. ANALYZER
K871892 · KNK
Technicon Instruments Corp.
Chemistry · 33d
Cleared Jun 17, 1987
PERM-CATH CATHETER KIT
K871942 · LFJ
Quinton, Inc.
Gastroenterology & Urology · 29d
Cleared Jun 17, 1987
BILATERAL CONTINUOUS PASSIVE MOTION DEVICE
K871981 · BXB
Avec Scientific Design Corp.
Physical Medicine · 26d
Cleared Jun 17, 1987
SPIRASEAL(TM) FACE MASK (VARIOUS SIZES)
K872015 · BSJ
Brigam, Inc.
Anesthesiology · 22d
Cleared Jun 17, 1987
UNI-FAST CREATINE KINASE TEST (CK)
K872029 · JHS
Sclavo, Inc.
Chemistry · 22d
Cleared Jun 17, 1987
KODAK EKTACHEM 700S ANALYZER
K872103 · JJE
Eastman Kodak Company
Chemistry · 16d
Cleared Jun 17, 1987
KODAK EKTACHEM 700P ANALYZER
K872104 · JJE
Eastman Kodak Company
Chemistry · 16d
Cleared Jun 17, 1987
ABBOTT SPECTRUM BICARBONATE REAGENT KIT
K872108 · KHS
Abbott Laboratories
Chemistry · 16d
Cleared Jun 17, 1987
8000 SERIES GAS CHROMATOGRAPHS
K872122 · KZQ
The Perkin-Elmer Corp.
Toxicology · 15d
Cleared Jun 17, 1987
TIPSEP-CORTISOL RIA DIAGNOSTIC KIT
K872177 · CGR
Nuclear Diagnostics, Inc.
Chemistry · 9d
Cleared Jun 16, 1987
LP-3 ELECTROCARDIOGRAPH
K864614 · DPS
Fidelity Medical, Inc.
Cardiovascular · 204d
Cleared Jun 16, 1987
MODEL 617 CARDIAC OUTPUT COMPUTER
K870375 · DXG
Omnimed B.V.
Cardiovascular · 138d
Cleared Jun 16, 1987
DYNATRON 438
K870515 · IPF
Henley Intl.
Physical Medicine · 131d
Cleared Jun 16, 1987
GUIDING CATHETERS 9F JL4
K871021 · DQO
Devices For Vascular Intervention, Inc.
Cardiovascular · 92d
Cleared Jun 16, 1987
ALLEVYN HYDROPHILIC POLYURETHANE DRESSING
K871166 · NAD
Smith & Nephew, Inc.
General & Plastic Surgery · 84d
Cleared Jun 16, 1987
RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125]
K871549 · KLN
Immunalysis Corporation
Chemistry · 63d
Cleared Jun 16, 1987
OVER DRAPE LEG HOLDER
K871900 · KQZ
Avec Scientific Design Corp.
Orthopedic · 32d
Cleared Jun 16, 1987
FRASTEC DRY BURN DRESSING
K871916 · EFQ
Fraass Survival Systems, Inc.
General & Plastic Surgery · 29d
Cleared Jun 16, 1987
FRASTEC DRY GAUZE BANDAGE
K871917 · EFQ
Fraass Survival Systems, Inc.
General & Plastic Surgery · 29d
Cleared Jun 15, 1987
SP55 SYRINGE PUMP
K870330 · FRN
Vickers , Ltd.
General Hospital · 138d
Cleared Jun 15, 1987
SENSIR SYSTEM
K870719 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 115d