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

Filters: Cleared only ×
176,076 results
168913–168936 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 1979
OXYGENATOR GAS LINE FILTER
K792151 · KRI
Cardio Systems, Inc.
Cardiovascular · 22d
Cleared Nov 13, 1979
CARDIOPLEGIA SOLUTION ADMIN. SET
K792152 · DWF
Cardio Systems, Inc.
Cardiovascular · 22d
Cleared Nov 13, 1979
DIGOXIN RADIOIMMUNOASSAY SYSTEM
K792153 · DPB
Radioimmunoassay, Inc.
Toxicology · 18d
Cleared Nov 13, 1979
THYROID STIMULATING HORMONE
K792154 · JLW
Radioimmunoassay, Inc.
Chemistry · 19d
Cleared Nov 13, 1979
DENTAL MOUTHPROP (BITE BLOCK)
K792157 · JXL
Mission Dental, Inc.
Neurology · 15d
Cleared Nov 13, 1979
125 I PROLACTIN HORMONE RIA KIT
K792166 · CFT
Diagnostic Products Corp.
Chemistry · 15d
Cleared Nov 13, 1979
125 I FOLATE SOLID PHASE RADIOASSAY
K792167 · CGN
Abbott Laboratories
Chemistry · 18d
Cleared Nov 13, 1979
LIFELINE - ENDOCARDIAL PACING LEAD
K792168 · DTB
Intermedics, Inc.
Cardiovascular · 15d
Cleared Nov 13, 1979
PERCUTANEOUS SHEATH (MULTI-CATH)SIDE
K792170 · DYB
Stanco Medical, Inc.
Cardiovascular · 15d
Cleared Nov 13, 1979
COMPLETE TRAY CENTRAL VENOUS PRESSURE
K792171 · DYB
Stanco Medical, Inc.
Cardiovascular · 15d
Cleared Nov 13, 1979
PERCUTANEOUS SHEATH INTRO. KIT OR TRAY
K792172 · DYB
Stanco Medical, Inc.
Cardiovascular · 15d
Cleared Nov 13, 1979
RIANEN, VITAMIN B12 ASSAY SYSTEM
K792175 · CDD
New England Nuclear
Chemistry · 15d
Cleared Nov 13, 1979
CORNING CONFIRM BLOOD GAS QUALITY CONTRO
K792180 · JJS
Corning Medical & Scientific
Chemistry · 15d
Cleared Nov 13, 1979
DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO
K792183 · LBS
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 15d
Cleared Nov 13, 1979
NORDICLAB TOTAL ESTRIOL RIA TEST
K792189 · CGI
Nordiclab Intl.
Chemistry · 13d
Cleared Nov 13, 1979
VITA-STAT MODEL 900A
K792192 · DXN
Vita-Stat Medical Services, Inc.
Cardiovascular · 12d
Cleared Nov 13, 1979
8 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO
K792196 · JJR
Photovolt Corp.
Chemistry · 12d
Cleared Nov 07, 1979
ELA MEDICAL ANATEC HOLTER SCANNER
K792239
Ela Medical, Inc.
Cardiovascular
Cleared Nov 05, 1979
PROTEIN ASSAY KIT
K790808 · CEK
Specialty Medical Industries, Inc.
Chemistry · 193d
Cleared Nov 05, 1979
RIA KIT FOR TRYPSIN
K791202 · JNO
Cis Radiopharmaceuticals, Inc.
Chemistry · 130d
Cleared Nov 05, 1979
MINISPIROMETER SP-1
K791422 · BZG
Renesco International, Inc.
Anesthesiology · 112d
Cleared Nov 05, 1979
BLADDER RETENTION CATHETERIZATION TRAY
K791674 · KOD
Latex Ind., Inc.
Gastroenterology & Urology · 70d
Cleared Nov 05, 1979
AR/MDE INFUSOR MODEL 60/2 INFUSION PUMP
K791720 · FRN
Alza Corp.
General Hospital · 67d
Cleared Nov 05, 1979
RIONET HEARING AID MODEL HA-55
K791739 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 66d