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
162745–162768 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 1981
FOGARTY FLEXIBLE PROBE
K812935 · DWP
American Edwards Laboratories
Cardiovascular · 27d
Cleared Nov 16, 1981
MILLAR MIKRO-TIP CATHETER PRESSURE TRAN.
K812944 · DRF
Millar Instruments, Inc.
Cardiovascular · 27d
Cleared Nov 16, 1981
EAST VENTILARM PRESSURE MONITOR ALARM S.
K812960 · CAP
Cairco , Ltd.
Anesthesiology · 26d
Cleared Nov 16, 1981
INTRODUCER, PERCUTANEOUS SELDINGER
K812964 · DYB
Triad Medical Division
Cardiovascular · 25d
Cleared Nov 16, 1981
PERCUTANEOUS INTRODUCER COURNAND STYLE
K812973 · DYB
Dip, Inc.
Cardiovascular · 24d
Cleared Nov 16, 1981
LANCER COAGENT HUMAN FACTOR 1X PLASMA
K812974 · GGP
Sherwood Medical Co.
Hematology · 24d
Cleared Nov 16, 1981
LANCER COAGENT HUMAN VACTOR VIII PLASMA
K812975 · GGP
Sherwood Medical Co.
Hematology · 24d
Cleared Nov 16, 1981
RESPIRATORY CARE MONITOR
K812977 · BZA
Advanced Medical Equipment, Inc.
Anesthesiology · 24d
Cleared Nov 16, 1981
INTERMEDICS POLYFLEX-MODEL 493-03 LEAD
K812989 · DTB
Intermedics, Inc.
Cardiovascular · 21d
Cleared Nov 16, 1981
INTERMEDICS POLYFLEX-MODEL 483-03 LEAD
K812990 · DTB
Intermedics, Inc.
Cardiovascular · 21d
Cleared Nov 16, 1981
INTERMEDICS POLYFLEX-MODEL 483-04 LEAD
K812991 · DTB
Intermedics, Inc.
Cardiovascular · 21d
Cleared Nov 16, 1981
PET POLYETHYLENE TORQUE CATHETER
K812999 · DQO
Universal Medical Instrument Corp.
Cardiovascular · 21d
Cleared Nov 16, 1981
EEG TELEPHONE TRANSMITTER, MODEL #T-7
K813010 · GYE
Pharmaquest Corp.
Neurology · 20d
Cleared Nov 16, 1981
PERCUTANEOUS INTRODUCER: SELDINGER STYLE
K813019 · DYB
Dip, Inc.
Cardiovascular · 20d
Cleared Nov 16, 1981
DISPOSABLE BLOOD PRESSURE TRANSDUCER DOM
K813053 · DRS
Bentley Laboratories, Inc.
Cardiovascular · 18d
Cleared Nov 16, 1981
LEECO TESTO-QUANT DIAG. KIT
K813059 · CDZ
Leeco Diagnostics, Inc.
Chemistry · 17d
Cleared Nov 16, 1981
ARGYLE YANKAUER SUCTION TUBE
K813066 · GCX
Sherwood Medical Co.
General Hospital · 17d
Cleared Nov 16, 1981
PERITONEAL DIALYSIS CYCLER SET
K813069 · KDJ
American Medical Products, Inc.
Gastroenterology & Urology · 17d
Cleared Nov 16, 1981
PHOSPHOTUNGSTATE REDUCTION, URIC ACID
K813076 · CDH
American Monitor Corp.
Chemistry · 14d
Cleared Nov 16, 1981
TECHNICON RA 1000 SYSTEM
K813077 · JJC
Technicon Corp.
Chemistry · 14d
Cleared Nov 16, 1981
VENOFIX SCALP VEIN SET
K813083 · FPA
Burron Medical Products, Inc.
General Hospital · 14d
Cleared Nov 13, 1981
STERILE WATER 4OZ.
K812312 · JOL
Superior Plastic Products Corp.
General Hospital · 88d
Cleared Nov 10, 1981
PRE-FILLED SYRINGE & CYSTOFLO URINARY BG
K811924 · KOD
Travenol Laboratories, S.A.
Gastroenterology & Urology · 131d
Cleared Nov 10, 1981
LORENZ BLOOD GAS ANALYZER
K812090 · CHL
Lorenz Instruments
Chemistry · 79d