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
83041–83064 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 2000
PR3 ULTRASOUND SYSTEM
K993978 · IYO
Carolina Medical, Inc.
Radiology · 78d
Cleared Feb 10, 2000
HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM
K994196 · LJT
Horizon Medical Products, Inc.
General Hospital · 59d
Cleared Feb 10, 2000
EASY CARE AND TUBING SETS
K994218 · FKX
Medionics International, Inc.
Gastroenterology & Urology · 57d
Cleared Feb 10, 2000
NASOGASTRIC TUBE HOLDER, MODEL 160
K994300 · KNT
Dale Medical Products, Inc.
Gastroenterology & Urology · 51d
Cleared Feb 10, 2000
BACT/ALERT SV
K994343 · MDB
Organon Teknika Corp.
Microbiology · 49d
Cleared Feb 10, 2000
OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS
K994435 · EIH
Jeneric/Pentron, Inc.
Dental · 42d
Cleared Feb 09, 2000
BIOTEQUE HEMODIALYSIS BLOOD TUBING SET
K992930 · FJK
Bioteque Corp.
Gastroenterology & Urology · 162d
Cleared Feb 09, 2000
SHANGHAI POSEIDON POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW
K992979 · LYZ
Shanghai Poseidon Plastic Products...
General Hospital · 159d
Cleared Feb 09, 2000
HSV-1 ELISA IGG, MODEL EL0910G
K993754 · MXJ
Mrl Diagnostics
Microbiology · 96d
Cleared Feb 09, 2000
AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10
K993832 · MEB
Tandem Medical, Inc.
General Hospital · 89d
Cleared Feb 09, 2000
AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES (VIOLET, BLUE, GREEN AND PINK),...
K993912 · LYY
Latexx Partners, Inc.
General Hospital · 84d
Cleared Feb 09, 2000
POLYGLYCOLIC ACID
K994001 · GAM
Trading Consultants and Distributors...
General & Plastic Surgery · 77d
Cleared Feb 09, 2000
POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING...
K994162 · LYY
Allegiance Healthcare Corp.
General Hospital · 62d
Cleared Feb 08, 2000
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K000094 · MNH
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 26d
Cleared Feb 08, 2000
GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150
K000102 · CFR
Teco Diagnostics
Chemistry · 26d
Cleared Feb 08, 2000
ARTHRO-SURGIMAT-A103
K000153 · HRX
W.O.M. World of Medicine GmbH
Orthopedic · 21d
Cleared Feb 08, 2000
CLICK'X
K992739 · MNH
Synthes Spine
Orthopedic · 176d
Cleared Feb 08, 2000
ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE
K993818 · DWF
California Medical Laboratories, Inc.
Cardiovascular · 90d
Cleared Feb 08, 2000
CEREC 3
K994172 · ELW
Sirona Dental Systems GmbH
Dental · 60d
Cleared Feb 08, 2000
SUTRALON NYLON SUTURES
K994176 · GAR
Visionary Medical Supplies, Inc.
General & Plastic Surgery · 60d
Cleared Feb 08, 2000
SUTRASILK SILK SUTURE
K994177 · GAP
Visionary Medical Supplies, Inc.
General & Plastic Surgery · 60d
Cleared Feb 08, 2000
SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T
K994191 · HCI
Nmt Medical, Inc.
Neurology · 57d
Cleared Feb 08, 2000
FRONTAL SINUS TREPHINATION CANNULA
K994262 · KAM
Xomed, Inc.
General & Plastic Surgery · 53d
Cleared Feb 08, 2000
BITX PROBES
K994336 · GEI
Everest Medical Corp.
General & Plastic Surgery · 47d