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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
75913–75936 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 27, 2002
DIODENT DENTAL LASER SYSTEM
K013216 · GEX
Continuum Electro-Optics, Inc.
General & Plastic Surgery · 154d
Cleared Feb 27, 2002
INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC...
K013651 · DSY
Intervascular
Cardiovascular · 113d
Cleared Feb 27, 2002
PULSION FS LASER KERATOME
K013941 · GEX
Intra Lase Corp.
General & Plastic Surgery · 90d
Cleared Feb 27, 2002
FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM
K013946 · NEY
Afx, Inc.
General & Plastic Surgery · 90d
Cleared Feb 27, 2002
LIFESTITCH SUTURING DEVICE
K013990 · GAT
Edwards Lifesciences, LLC
General & Plastic Surgery · 86d
Cleared Feb 27, 2002
PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE
K014059 · DYH
Pulpdent Corp.
Dental · 79d
Cleared Feb 27, 2002
1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
K014115 · BTM
Portex, Inc.
Anesthesiology · 75d
Cleared Feb 27, 2002
PADPRO, MODEL 2603
K020288 · MKJ
Padpro, LLC
Cardiovascular · 30d
Cleared Feb 27, 2002
EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER
K020291 · JDI
Exactech, Inc.
Orthopedic · 30d