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
154345–154368 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 1984
PROBES, VARIOUS
K841003 · KOA
Premier Dental Products Co.
Gastroenterology & Urology · 11d
Cleared Mar 20, 1984
ALU-KART
K841178
Micro Encapsulation Tech.
Gastroenterology & Urology
Cleared Mar 20, 1984
HEMO-KART
K841179
Micro Encapsulation Tech.
Gastroenterology & Urology
Cleared Mar 20, 1984
DIA-KART
K841180
Micro Encapsulation Tech.
Gastroenterology & Urology
Cleared Mar 19, 1984
CM-VII PHYSIOLOGIC ANALYZER
K831586 · BZM
Cybermedic, Inc.
Anesthesiology · 307d
Cleared Mar 19, 1984
SERALYZER THEOPHYLLINE REAGENT STRIPS
K832825 · KLS
Miles Laboratories, Inc.
Toxicology · 213d
Cleared Mar 19, 1984
DEMAND OXYGEN CONTROLLER
K833351 · BZB
Healthdyne, Inc.
Anesthesiology · 173d
Cleared Mar 19, 1984
PEDIATRIC RIGHT ATRIAL CATHETER 1/3MM
K833442 · LJS
Quinton, Inc.
General Hospital · 166d
Cleared Mar 19, 1984
MODIFIED HPS HIP PROSTHESIS
K833599 · KWL
Depuy, Inc.
Orthopedic · 159d
Cleared Mar 19, 1984
SURGICAL VESSEL DILATORS-CATHERIZA-
K833676 · DWP
Cimed Intl., Inc.
Cardiovascular · 157d
Cleared Mar 19, 1984
SANI CATCH BA
K833814 · LIO
Concord Laboratories, Inc.
Microbiology · 138d
Cleared Mar 19, 1984
HCG RIA
K833851 · JHI
Syncor Intl. Corp.
Chemistry · 136d
Cleared Mar 19, 1984
MELOLITE
K833954 · KGX
Smith & Nephew, Inc.
General & Plastic Surgery · 124d
Cleared Mar 19, 1984
SERALYZER DRUG ASSAY CONTROL SERUM
K833977 · DLJ
Miles Laboratories, Inc.
Toxicology · 123d
Cleared Mar 19, 1984
SPINAL CORD STIMULATION SYS SE-4
K833990 · GZB
Medtronic Vascular
Neurology · 119d
Cleared Mar 19, 1984
PERCUTANEOUS SHEATH INTRODUCER TRAY
K834074 · DYB
Packaging Technologies, Inc.
Cardiovascular · 115d
Cleared Mar 19, 1984
ETHYLENE OXIDE DETECTOR GLD-1-07
K834152 · FLE
Calnor of EL Paseo, Inc.
General Hospital · 109d
Cleared Mar 19, 1984
DESERET SUBCLAVIAN JUGULAR CATH. SET
K834227 · FOZ
Parke-Davis Co.
General Hospital · 104d
Cleared Mar 19, 1984
ACUFEX DREZ COMMUNICATING DRILL GUIDE
K834350 · FZX
Acufex Microsurgical, Inc.
General & Plastic Surgery · 97d
Cleared Mar 19, 1984
OK FLASH STERILIZATION INDICATOR
K834353 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 97d
Cleared Mar 19, 1984
OPHTEC RUST RING REMOVER
K834354 · HOG
Jedmed Instrument Co.
Ophthalmic · 97d
Cleared Mar 19, 1984
STERILE DISPOSABLE SPINAL NEEDLES
K834407 · FMI
Hydro-Med Products, Inc.
General Hospital · 96d
Cleared Mar 19, 1984
DISPOS. SCOTT CANNULAS 16-1054 ETC.
K834477 · HCA
Codman & Shurtleff, Inc.
Neurology · 90d
Cleared Mar 19, 1984
EMIT ST. URINE COCAINE METABOLITE
K834549 · DIO
Syva Co.
Toxicology · 83d