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
166441–166464 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 1980
DIGITAL SUBTRACTION RADIOGRAPHY SYSTEM
K801948 · JAA
Technicare Corp.
Radiology · 42d
Cleared Sep 26, 1980
API-CTS STREPTOCOCCUS
K801951 · JTO
Analytical Products, Inc.
Microbiology · 39d
Cleared Sep 26, 1980
MICRO-FLOW SPECTROPHOTOMETER CL-720
K801957 · JJQ
Shimadzu Precision Instruments, Inc.
Chemistry · 39d
Cleared Sep 26, 1980
HEMO-CATH II KIDNEY DIALYSIS CATHETER
K801966 · FIE
Medical Components, Inc.
Gastroenterology & Urology · 38d
Cleared Sep 26, 1980
MEDCOMP FEMORAL VEIN CATHETER
K801967 · FIF
Medical Components, Inc.
Gastroenterology & Urology · 38d
Cleared Sep 26, 1980
HEMOCATH I KIDNEY DIALYSIS CATHETER
K801968 · LBW
Medical Components, Inc.
Gastroenterology & Urology · 38d
Cleared Sep 26, 1980
SCANLAN STERNUM NEEDLE-SUTURE
K801976 · GAB
Scanlan Intl., Inc.
General & Plastic Surgery · 38d
Cleared Sep 26, 1980
PROGRAMALITH #'S 221, 222, 221A & 222A
K801978 · DXY
Pacesetter Systems
Cardiovascular · 38d
Cleared Sep 26, 1980
NORDICLAB PROSTATIC ACID PHOSPHATASE RIA
K801988 · JFH
Nordiclab Intl.
Chemistry · 38d
Cleared Sep 26, 1980
PEDIWET=GUAZE IMPREGNATED WITH PETROL
K802007 · FRQ
Pollak (Intl.), Ltd.
Gastroenterology & Urology · 37d
Cleared Sep 26, 1980
BALLOON RETENTION CHEST CATHETER
K802025 · GBA
Loseff Medical Designers, Ltd.
General & Plastic Surgery · 37d
Cleared Sep 26, 1980
IMPLANTABLE VENTRICULAR-INHIB. C.P. GEN
K802028 · DXY
Telectronics, Inc.
Cardiovascular · 36d
Cleared Sep 26, 1980
OXFORD INTENSIVE CARE PATIENT MON. SYS
K802033 · DSI
Oxford Medilog, Inc.
Cardiovascular · 35d
Cleared Sep 26, 1980
BAKER DIAG. ULTRARATE CO2 REAGENT KIT
K802035 · JFL
J.T. Baker Chemical Co.
Chemistry · 35d
Cleared Sep 26, 1980
RIONET HEARING AID HB-69C
K802053 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 32d
Cleared Sep 26, 1980
DATA-ZYME UREA NITROGEN REAGENT SET
K802061 · CDQ
Data Medical Associates, Inc.
Chemistry · 32d
Cleared Sep 26, 1980
DUPONT ACALACTIC ACID (LA) TEST
K802064 · KHP
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 30d
Cleared Sep 26, 1980
CLEAN-AIR POLLUTION REDUCTION SYSTEM
K802067 · CBN
Porter Instrument Co., Inc.
Anesthesiology · 30d
Cleared Sep 26, 1980
PROT-A-TRAC
K802072 · HST
Robert I. Branick, M.D.
Neurology · 30d
Cleared Sep 26, 1980
STIFF STYLETS
K802076 · DRB
Cardiac Pacemakers, Inc.
Cardiovascular · 29d
Cleared Sep 26, 1980
AULD BAGGER KIT
K802081 · BTM
Modern Medical Systems Co.
Anesthesiology · 29d
Cleared Sep 26, 1980
CARDIOTRAK
K802089 · DXH
Cardiac Pacemakers, Inc.
Cardiovascular · 24d
Cleared Sep 26, 1980
DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC
K802090 · CAP
Draeger Medical, Inc.
Anesthesiology · 24d
Cleared Sep 26, 1980
GABBAY-FRATER SUTURE GUIDE
K802093 · FZX
Howmedica Corp.
General & Plastic Surgery · 24d