FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
76417–76440 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 2002
CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM
K012357 · MOI
Bayer Diagnostics Corp.
Immunology · 218d
Cleared Feb 28, 2002
RESPIRONICS HEATED HUMIDIFIER
K012633 · BTT
Respironics, Inc.
Anesthesiology · 199d
Cleared Feb 28, 2002
ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS
K012640 · HRX
Medical Instruments Technology, Inc.
Orthopedic · 199d
Cleared Feb 28, 2002
SOF-TACT DIABETES MANAGEMENT SYSYEM
K012975 · NBW
Abbott Laboratories
Chemistry · 176d
Cleared Feb 28, 2002
BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)
K013148 · MYA
Biogenex Laboratories
Pathology · 161d
Cleared Feb 28, 2002
URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM
K013819 · JTW
Sierra Diagnostic, LLC
Microbiology · 104d
Cleared Feb 28, 2002
SANDHILL SCIENTIFIC PEDIATEC PH PROBE
K013951 · FFT
Sandhill Scientific, Inc.
Gastroenterology & Urology · 90d
Cleared Feb 28, 2002
INTUITIVE SURGICAL STERO VIEW ENDOSCOPIC SYSTEM
K013952 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 90d
Cleared Feb 28, 2002
LORENZ SELF DRILLING SCREWS
K013954 · HWC
Walter Lorenz Surgical, Inc.
Orthopedic · 90d
Cleared Feb 28, 2002
MODEL 9210 DELIVERY CATHETER, MODEL 9210
K013963 · DQY
Medtronic Vascular
Cardiovascular · 87d
Cleared Feb 28, 2002
APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE
K014047 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 83d
Cleared Feb 28, 2002
SATARI POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM...
K014110 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 76d
Cleared Feb 28, 2002
SATARI LATEX PATIENT EXAMINATION POWDERED GLOVE SINGLE SIDE POLYMER COATED,...
K014112 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 76d
Cleared Feb 28, 2002
UNITE BONDING ADHESIVE
K014142 · DYH
3M Unitek
Dental · 73d
Cleared Feb 28, 2002
ABX MICROS 60 HEMATOLOGY ANALYZER
K014203 · GKX
Abx Diagnostics
Hematology · 69d
Cleared Feb 28, 2002
STAT PROFILE PHOX ANALYZER
K014295 · CHL
Nova Biomedical Corp.
Chemistry · 62d
Cleared Feb 28, 2002
DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636,...
K020023 · MXZ
Dako Corp.
Pathology · 56d
Cleared Feb 28, 2002
PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM
K020115 · DYH
Pulpdent Corp.
Dental · 48d
Cleared Feb 28, 2002
GC FUJI LINING LC PASTE PAK
K020117 · EMA
GC America, Inc.
Dental · 45d
Cleared Feb 28, 2002
VENUS UNIVERSAL LIGHT CURING COMPOSITE
K020131 · EBF
Heraeus Kulzer, Inc.
Dental · 44d
Cleared Feb 28, 2002
OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC)...
K020193 · LPL
Cl Mcintosh
Ophthalmic · 41d
Cleared Feb 28, 2002
JAS AMYLASE LIQUID REAGENT
K020282 · JFJ
Jas Diagnostics, Inc.
Chemistry · 31d
Cleared Feb 28, 2002
ADVANTAGE WORKSTATION 4.1
K020483 · LLZ
GE Medical Systems
Radiology · 15d
Cleared Feb 28, 2002
INFRARED EAR THERMOMETER, MODELS TH88 SERIES
K020504 · FLL
Radiant Innovation, Inc.
General Hospital · 13d