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
147553–147576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 1985
P.A. ENTERAL FEEDING BAG 1100
K853309 · KNT
Pa Medical Corp.
Gastroenterology & Urology · 20d
Cleared Aug 27, 1985
H-H SEXTON SCUP URINE MGMT. SYS
K853458 · KNX
Holter-Hausner Intl.
Gastroenterology & Urology · 11d
Cleared Aug 26, 1985
TRIPLE LUMEN RIGHT ATRIAL CATHETER
K852815 · DQY
Quinton, Inc.
Cardiovascular · 55d
Cleared Aug 26, 1985
LAURIER OVERNIGHT SANITARY NAPKIN
K852922 · HHD
Kao Corp.
Obstetrics & Gynecology · 48d
Cleared Aug 26, 1985
PHOENIX ANESTHESIA MACHINE
K853139 · BSZ
American Anesthesia, Inc.
Anesthesiology · 38d
Cleared Aug 26, 1985
ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543
K853265
Geneva Laboratories, Inc.
General & Plastic Surgery · 21d
Cleared Aug 26, 1985
FETAL BOVINE SERUM IN TRANSFER CONTAINER
K853441 · KJA
Newport Biosystems, Inc.
Pathology · 13d
Cleared Aug 23, 1985
CHERMEL SCALP VEIN SET
K851516 · FPA
Cher Mel Corp.
General Hospital · 130d
Cleared Aug 23, 1985
GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT
K851703 · CGA
Miles Laboratories, Inc.
Chemistry · 121d
Cleared Aug 23, 1985
UNSCENTED MENSTRUAL TAMPONS
K851941 · HEB
Personal Products Co.
Obstetrics & Gynecology · 112d
Cleared Aug 23, 1985
ALLOY 7
K852093 · EJS
Williams Gold Refining Co., Inc.
Dental · 101d
Cleared Aug 23, 1985
MODEL 451 CO2 SURGICAL LASER
K852190 · GEX
Coherent Medical Group
General & Plastic Surgery · 93d
Cleared Aug 23, 1985
DENTOLOCK II DENTURE ADHESIVE CREAM
K852926
Solar Dental Co., Inc.
Dental · 45d
Cleared Aug 23, 1985
BOEHRINGER LABORATORIES SUCTION INTERMITTOR
K853095 · GCX
Boehringer Laboratories
General Hospital · 31d
Cleared Aug 23, 1985
MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR
K853152 · JKA
Sherwood Medical Co.
Chemistry · 25d
Cleared Aug 23, 1985
OMNIMED I.V. SOLUTION ADMIN. SET
K853255 · FPA
Omni Intl., Inc.
General Hospital · 21d
Cleared Aug 23, 1985
CENTRIX RIBBON TUBES
K853282 · EID
Centrix, Inc.
Dental · 18d
Cleared Aug 23, 1985
TROCAR/CANNULA/SHEATH SET
K853337 · KOD
American Edwards Laboratories
Gastroenterology & Urology · 14d
Cleared Aug 23, 1985
DELTA TROL I & II
K853373 · JJT
Electro-Nucleonics Laboratories, Inc.
Chemistry · 11d
Cleared Aug 23, 1985
I.A.S.S., IV SET W/AIR VENT & I.A.P.S. W/O AIRVENT
K853385 · FPA
Migada, Ltd.
General Hospital · 11d
Cleared Aug 23, 1985
QCA POTASSIUM TEST KIT
K853404 · CEJ
Bd Becton Dickinson Vacutainer...
Chemistry · 11d
Cleared Aug 22, 1985
DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO
K850482 · DSP
Datascope Corp.
Cardiovascular · 196d
Cleared Aug 22, 1985
KINNET
K851875 · INY
Kinetic Concepts, Inc.
Physical Medicine · 115d
Cleared Aug 22, 1985
EXTERNAL MALE CATHETER
K852051 · KNX
Buffalo Medical Specialties Mfg., Inc.
Gastroenterology & Urology · 105d