FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
161905–161928 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 10, 1981
MULTI CLOT-#819
K812122 · JPA
Volu Sol Medical Industries
Hematology · 106d
Cleared Nov 10, 1981
BACTEC RESIN CULTURE MED. 16A
K812315 · MDB
Bd Becton Dickinson Vacutainer...
Microbiology · 85d
Cleared Nov 10, 1981
LINUS
K812398 · IYO
Fischer Imaging Corp.
Radiology · 82d
Cleared Nov 10, 1981
IMMUNO-CELL IMMUNO-SEP KIT
K812411 · JCF
Kallestad Laboratories, Inc.
Hematology · 81d
Cleared Nov 10, 1981
UNIVERSAL SUTURE PASSER
K812566 · GDL
Ortho Pared Instruments, Inc.
General & Plastic Surgery · 62d
Cleared Nov 10, 1981
RELIEF
K812567 · LKX
American Pharmaceutical Co., Inc.
Gastroenterology & Urology · 62d