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
83545–83568 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 2000
MU PLUS
K992689 · IYE
Rad Therapy Solutions, Inc.
Radiology · 184d
Cleared Feb 10, 2000
R1000 SERIES INSULIN PUMP
K993184 · LZG
Animas Corp.
General Hospital · 140d
Cleared Feb 10, 2000
ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT...
K993190 · HNO
Surgical Instrument Systems (Sis), Ltd.
Ophthalmic · 140d
Cleared Feb 10, 2000
COPALIS RUBELLA IGM
K993291 · LFX
DiaSorin, Inc.
Microbiology · 132d
Cleared Feb 10, 2000
YEASTEST
K993554 · JXB
Diagnostic Markers, Inc.
Microbiology · 113d
Cleared Feb 10, 2000
FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D...
K993861 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 87d
Cleared Feb 10, 2000
ULTRABLATOR ELECTRODE
K993885 · JOS
Linvatec Corp.
General & Plastic Surgery · 86d
Cleared Feb 10, 2000
MEDX INTECAM INTERFACE
K993893 · KPS
Medx, Inc.
Radiology · 86d
Cleared Feb 10, 2000
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE...
K993918 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 84d
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