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
153913–153936 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 1984
RESPIRATION/8100-HEART RATE RECORDER
K833348 · DSH
Aequitron Medical, Inc.
Cardiovascular · 203d
Cleared Apr 17, 1984
EVENT TAPE RECORDER 8293
K833349 · DSH
Aequitron Medical, Inc.
Cardiovascular · 203d
Cleared Apr 17, 1984
COOPER MEDICAL MODEL 770
K833497 · LLF
Cooper Medical Corp.
Neurology · 189d
Cleared Apr 17, 1984
CONTRAST MEDIA INJECT. SET CMS
K833645 · DXT
Gish Biomedical, Inc.
Cardiovascular · 183d
Cleared Apr 17, 1984
ISOTEC DISPOS. PRESSURE TRANSDUCER
K833884
Delta Medical Industries
Cardiovascular · 160d
Cleared Apr 17, 1984
CO-SET
K833997
American Edwards Laboratories
General & Plastic Surgery · 148d
Cleared Apr 17, 1984
RUBAQUICK DIAGNOSTIC KIT
K834032 · GOL
Abbott Laboratories
Hematology · 147d
Cleared Apr 17, 1984
SARNS 8.0 SOFT ARC CANNULA
K834134 · DWF
3M Health Care, Sarns
Cardiovascular · 139d
Cleared Apr 17, 1984
HOLTER CARDIOGRAPHY SYS 6201
K834397 · DSI
Instruments For Cardiac Research
Cardiovascular · 125d
Cleared Apr 17, 1984
ALPHA MASS STORAGE CARDULE 1895
K834597 · DSI
Spacelabs, Inc.
Cardiovascular · 109d
Cleared Apr 17, 1984
MICROFUSE INTRAVENOUS CATHETER SET
K840240 · DQY
Norton Performance Plastics Corp.
Cardiovascular · 88d
Cleared Apr 17, 1984
MINI-DEFIBRILLATOR 280/4
K840246 · LDD
Life Science Instrumentation, Inc.
Cardiovascular · 96d
Cleared Apr 17, 1984
CARDIOFAX ECG 6543
K840274 · DRS
Nihon Kohden America, Inc.
Cardiovascular · 85d
Cleared Apr 17, 1984
ANGIOGRAPHIC DRAPE PACKS
K840281 · DXT
Medrad, Inc.
Cardiovascular · 85d
Cleared Apr 17, 1984
MCA IN THE EAR CUSTOM HEARING AID
K840298 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 84d
Cleared Apr 17, 1984
HAEMOPHILUS I.D. II TRIPLATE
K840338 · JSI
Remel Co.
Microbiology · 83d
Cleared Apr 17, 1984
RETROGRADE INFUSION SET 3ML & 6ML-
K840443 · FPA
Tico Medical Instruments, Inc.
General Hospital · 76d
Cleared Apr 17, 1984
SHILEY PREBYPASS FILTER
K840450 · KRJ
Shiley, Inc.
Cardiovascular · 76d
Cleared Apr 17, 1984
BIOTIS ABNORMAL CLINICAL CHEM SERUM-
K840458 · JJY
Otisville Biotech, Inc.
Microbiology · 75d
Cleared Apr 17, 1984
FLUID REMOVAL ASSEMBLY
K840490 · FMF
Ackrad Laboratories
General Hospital · 71d
Cleared Apr 17, 1984
RESIL
K840548 · EBI
Parker Laboratories, Inc.
Dental · 69d
Cleared Apr 17, 1984
NEONATAL PHYSIOLOGICAL MONITOR 903
K840560 · DRT
Novametrix Medical Systems, Inc.
Cardiovascular · 69d
Cleared Apr 17, 1984
PEDIATRIC ARTERIAL BLOOD FILTER
K840612 · DTM
American Bentley
Cardiovascular · 64d
Cleared Apr 17, 1984
HARRIS-GALANTE POROUS TOTAL HIP SYS
K840643 · JDI
Zimmer, Inc.
Orthopedic · 62d