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
157801–157824 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 1983
ASEPTIC FLUID TRANSFER SYSTEM
K830811 · KQQ
Steridoc Corp.
Gastroenterology & Urology · 44d
Cleared Apr 28, 1983
FRENCH PERCUTANEOUS SHEATH INTRODUCER
K830813 · DYB
Norton Performance Plastics Corp.
Cardiovascular · 45d
Cleared Apr 28, 1983
IMPLANTABLE PACING LEAD CCS MODEL SV-101
K830828 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 43d
Cleared Apr 28, 1983
CORONARY GUIDING CATHETER
K830829 · DYB
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 45d
Cleared Apr 28, 1983
BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU-
K830843 · JKT
Rna Medical Corp.
Chemistry · 42d
Cleared Apr 28, 1983
SINGLE USE NEBULIZER, ADJUST. AIR-
K830895 · CAF
Airlife, Inc.
Anesthesiology · 38d
Cleared Apr 28, 1983
VENTREX ENZYME TSH KIT
K830928 · JLW
Ventrex Laboratories, Inc.
Chemistry · 36d
Cleared Apr 28, 1983
PREFILLED RESPIRATORY THERAPY VIAL
K830943 · CAF
Automatic Liquid Packaging, Inc.
Anesthesiology · 35d
Cleared Apr 28, 1983
MALE EXTERNAL CATHETER
K830946 · KNX
Post Medical, Inc.
Gastroenterology & Urology · 35d
Cleared Apr 28, 1983
HELENA BIOSTRIP P
K830977 · JIR
Helena Laboratories
Chemistry · 30d
Cleared Apr 28, 1983
POCKET SPIROMETER
K830995 · BZK
P.K. Morgan Instruments, Inc.
Anesthesiology · 30d
Cleared Apr 28, 1983
ANDREWS REMOTE CHUCK DRILL
K831043 · HXY
Orthopedic Systems, Inc.
Orthopedic · 28d
Cleared Apr 28, 1983
DEFIBRILLATOR VPD 545
K831056 · LDD
Life Science Instrumentation, Inc.
Cardiovascular · 27d
Cleared Apr 28, 1983
P & T MEDIUM
K831059 · JSM
American Micro Scan
Pathology · 27d
Cleared Apr 28, 1983
OSCAR COLOR VISION TESTER
K831074 · HIT
Carl Zeiss, Inc.
Ophthalmic · 24d
Cleared Apr 28, 1983
COMPRESSION SYSTEM
K831076 · JDO
Kirschner Medical Corp.
Orthopedic · 24d
Cleared Apr 28, 1983
LIQUIPETTE
K831079 · GJG
The Kendall Company Div. of Tyco...
Hematology · 24d
Cleared Apr 28, 1983
MINI-VOL EXTENSION SET
K831087 · FPA
Beech Medical, Inc.
General Hospital · 24d
Cleared Apr 28, 1983
MINI-VOL I.V. SET
K831088 · FPA
Beech Medical, Inc.
General Hospital · 24d
Cleared Apr 28, 1983
INFUSION PUMP
K831089 · FLL
Beech Medical, Inc.
General Hospital · 24d
Cleared Apr 28, 1983
CURITY LEG BAG
K831121 · KNX
The Kendal Co.
Gastroenterology & Urology · 23d
Cleared Apr 28, 1983
PANASONIC MODEL HV-5
K831150 · FLL
Panasonic Co. Div. Matsu Elec. Corp....
General Hospital · 20d
Cleared Apr 28, 1983
I/A KIT
K831159 · JSM
Staar Surgical Co.
Microbiology · 17d
Cleared Apr 28, 1983
TOP-FILL BAG
K831169 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 17d