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
137161–137184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 1988
DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER
K874442 · DQA
Critikon Company, LLC
Anesthesiology · 113d
Cleared Feb 18, 1988
GLASS IONOMERS-BIO-GLASS BASE/LINING & LUTING CEM.
K874500 · EMA
Harry J. Bosworth Co.
Dental · 108d
Cleared Feb 18, 1988
PRECEPT(TM) CIPROFLOXACIN
K874727 · JWY
Austin Biological Laboratories
Microbiology · 92d
Cleared Feb 18, 1988
LYPHOCHEK WHOLE BLOOD CONTROL
K874731 · JJY
Bio-Rad
Chemistry · 92d
Cleared Feb 18, 1988
CELLECT MODEL D, AUTOMATED HEMTALOGY ANALYZER
K874763 · GKZ
Instrumentation Laboratory CO
Hematology · 91d
Cleared Feb 18, 1988
COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5
K874808 · DJG
Diagnostic Products Corp.
Toxicology · 87d
Cleared Feb 18, 1988
ACS HI-TORQUE CORONARY GUIDING CATHETER W/SOFT TIP
K874874 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 83d
Cleared Feb 18, 1988
ACROMED CROSS ROD CONNECTOR
K874882 · KWP
Acromed Corp.
Orthopedic · 79d
Cleared Feb 18, 1988
CANYON MEDICAL FEMORAL BYPASS CANNULAE
K874899 · DWF
Canyon Medical Products
Cardiovascular · 79d
Cleared Feb 18, 1988
SUN MEDICAL SMOKE EVACUATOR SYSTEM
K874948 · GEX
Sun Medical, Inc.
General & Plastic Surgery · 78d
Cleared Feb 18, 1988
SARNS VENOATRIAL CATHETER
K875048 · DWF
3M Health Care, Sarns
Cardiovascular · 71d
Cleared Feb 18, 1988
ASPARTATE AMINOTRANSFERASE AST/SGOT
K875071 · CIT
Tech-Co, Inc.
Chemistry · 71d
Cleared Feb 18, 1988
STERI-CLENS
K875129 · GEC
Absorbent Cotton Co., Inc.
General & Plastic Surgery · 65d
Cleared Feb 18, 1988
THIELER KIT
K875153 · KKX
Taris Corp.
General Hospital · 65d
Cleared Feb 18, 1988
NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR
K875199 · DTB
Biotronik Sales, Inc.
Cardiovascular · 62d
Cleared Feb 18, 1988
SONOLINE CF
K875272 · DXK
Siemens Medical Laboratories, Inc.
Cardiovascular · 56d
Cleared Feb 18, 1988
MODIFIED OCCLUDER/FLUSHING CATHETER STOPCOCK
K875325 · DQO
Schneider-Shilley (Usa)
Cardiovascular · 51d
Cleared Feb 18, 1988
MODIFIED SCHNEIDER-SHILEY FLUSHING CATHETER
K875326 · DQO
Schneider-Shilley (Usa)
Cardiovascular · 51d
Cleared Feb 18, 1988
TOWNLEY COX COMB ACETABULAR CUP
K880004 · JDI
Orthomet, Inc.
Orthopedic · 45d
Cleared Feb 18, 1988
HIP, FEMUR AND HUMERUS RETRACTOR
K880151 · GAD
Twenty-First Century Orthopedics, Inc.
General & Plastic Surgery · 36d
Cleared Feb 18, 1988
BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000
K880166 · LFL
Clinical Technology Corp.
General & Plastic Surgery · 35d
Cleared Feb 18, 1988
HDL CHOLESTEROL PRECIPITATING REAGENT
K880176 · LBR
Tech-Co, Inc.
Chemistry · 34d
Cleared Feb 18, 1988
CREATINE KINASE (COLORIMETRIC METHOD)
K880178 · JHY
Tech-Co, Inc.
Chemistry · 34d
Cleared Feb 18, 1988
TSRH H/M TORQUE LIMITING WRENCH
K880214 · KWP
Warsaw Orthopedic, Inc.
Orthopedic · 30d