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
83737–83760 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 1999
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
K993729 · DQK
Biosense Webster, Inc.
Cardiovascular · 29d
Cleared Dec 03, 1999
GYRUS HYSTEROSCOPIC RESECTOSCOPE
K993749 · HIH
Gyrus Medical , Ltd.
Obstetrics & Gynecology · 28d
Cleared Dec 03, 1999
GLOVCO, POWDER-FREE CHLORINATED LATEX EXAMINATION GLOVES WITH PROTEIN...
K993752 · LYY
Glovco (M) Sdn. Bhd.
General Hospital · 28d
Cleared Dec 03, 1999
OBC-300 BREAST ARRAY COIL
K993776 · MOS
Mri Devices Corp.
Radiology · 25d
Cleared Dec 03, 1999
QWH-300 WRIST ARRAY COIL
K993819 · MOS
Mri Devices Corp.
Radiology · 23d
Cleared Dec 03, 1999
CATHETER INNOVATIONS IMPLANTABLE PORT
K993860 · LJT
Catheter Innovations, Inc.
General Hospital · 18d
Cleared Dec 02, 1999
ETHYL CHLORIDE DISPENSER
K984564 · MLY
Dukal Corp.
Physical Medicine · 344d
Cleared Dec 02, 1999
LC COMPOSITE
K991492 · EFB
Harry J. Bosworth Co.
Dental · 218d
Cleared Dec 02, 1999
AED ARTHROSCOPE
K991656 · HRX
National Advanced Endoscopy Devices,...
Orthopedic · 203d
Cleared Dec 02, 1999
ENSITE 3000 SYSTEM
K992479 · DQK
Endocardial Solutions, Inc.
Cardiovascular · 129d
Cleared Dec 02, 1999
MS-30 FEMORAL STEM
K993043 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 83d
Cleared Dec 02, 1999
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K993102 · LTT
Dade Microscan, Inc.
Microbiology · 77d
Cleared Dec 02, 1999
STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1...
K993104 · GLY
Nova Biomedical Corp.
Hematology · 77d
Cleared Dec 02, 1999
MULTI-COMFORT NITRILE EXAMINATION GLOVES, (POWDER FREE)
K993127 · LZA
Glovesworld Industries Sdn. Bhd.
General Hospital · 73d
Cleared Dec 02, 1999
DERMAGRIP POWDER-FREE LATEX SURGICAL GLOVE, STERILE (PROTEIN CONTENT LABELING...
K993214 · KGO
Wrp Specialty Products Sdn. Bhd.
General Hospital · 69d
Cleared Dec 02, 1999
DERMAGRIP POWDERED LATEX SURGICAL GLOVE, STERILE
K993215 · KGO
Wrp Specialty Products Sdn. Bhd.
General Hospital · 69d
Cleared Dec 02, 1999
TALON ANCHOR SNAP-PAK
K993261 · MBI
Mitek Products
Orthopedic · 64d
Cleared Dec 02, 1999
QUALITY LATEX POWDERED LATEX MEDICAL GLOVES WITH PROTEIN CONTENT LABELING...
K993271 · LYY
Quality Latex Corp. Sdn Bhd
General Hospital · 63d
Cleared Dec 02, 1999
POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR...
K993457 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 50d
Cleared Dec 02, 1999
DELTAPAL, ALLOY NO. 5161
K993474 · EJS
Metalor Dental USA Corp.
Dental · 49d
Cleared Dec 02, 1999
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50...
K993500 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 48d
Cleared Dec 02, 1999
CARESIDE ANALYZER
K993634 · JJF
Careside, Inc.
Chemistry · 36d
Cleared Dec 02, 1999
DURACON INSET PATELLA, 25MM
K993692 · JWH
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Dec 02, 1999
CLEARVIEW EASY HCG PREGNANCY TEST
K993703 · JHI
Unipath , Ltd.
Chemistry · 30d