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
69721–69744 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 18, 2003
DELTA SHOULDER
K021478 · PHX
Depuy, Inc.
Orthopedic · 559d
Cleared Nov 18, 2003
MARINA MEDICAL SILICONE PESSARY
K031463 · HHW
Marina Medical Instruments, Inc.
Obstetrics & Gynecology · 194d
Cleared Nov 18, 2003
PARADIGMPAL, MODEL MMT-7330
K031541 · LZG
Minimed, Inc.
General Hospital · 186d
Cleared Nov 18, 2003
SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND...
K031553 · BTO
Arcadia Medical Corporation
Anesthesiology · 183d
Cleared Nov 18, 2003
ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS
K031666 · HRS
Arthrex, Inc.
Orthopedic · 173d
Cleared Nov 18, 2003
XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
K031942 · MHI
Remel, Inc.
Microbiology · 147d
Cleared Nov 18, 2003
GLUCOSE TOLERANCE BEVERAGE
K032753 · MRV
Perk Scientific, Inc.
Chemistry · 74d
Cleared Nov 18, 2003
ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1
K032784 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 71d
Cleared Nov 18, 2003
PASCO MIC AND MIC/ID PANELS
K033119 · JWY
Pasco Laboratories, Inc.
Microbiology · 49d
Cleared Nov 18, 2003
BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER
K033350 · FPA
Becton, Dickinson & CO
General Hospital · 29d
Cleared Nov 18, 2003
MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT
K033473 · LJT
Horizon Medical Products, Inc.
General Hospital · 15d
Cleared Nov 17, 2003
STONE EXTRACTOR BALLOON CATHETER
K011261 · FGE
Medi-Globe Corp.
Gastroenterology & Urology · 936d
Cleared Nov 17, 2003
AURA ISURGICAL LASER SYSTEM & ACCESSORIES
K024206 · GEX
Laserscope
General & Plastic Surgery · 332d
Cleared Nov 17, 2003
GYRUS OPEN FORCEPS
K024286 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 329d
Cleared Nov 17, 2003
ARTELON SURGICAL SUTURE
K032160 · GAR
Artimplant AB
General & Plastic Surgery · 125d
Cleared Nov 17, 2003
CYNOSURE PHOTOGENICA SV LASER
K032539 · GEX
Cynosure, Inc.
General & Plastic Surgery · 91d
Cleared Nov 17, 2003
CAPROSYN ABSORBABLE SUTURE
K032586 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 87d
Cleared Nov 17, 2003
ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005
K032987 · JHI
Unotech Diagnostics, Inc.
Chemistry · 54d
Cleared Nov 17, 2003
ORTHODEK
K033115 · GAM
Teleflex Medical
General & Plastic Surgery · 48d
Cleared Nov 17, 2003
MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM
K033134 · FGE
Ev3, Inc.
Gastroenterology & Urology · 48d
Cleared Nov 14, 2003
ACCUMAP AUTOMATIC PERIMETER
K022304 · GWE
Objectivision Pty , Ltd.
Neurology · 486d
Cleared Nov 14, 2003
SHILEY FLEXTRA TRACHEOSTOMY TUBE
K030787 · JOH
Nellcor Puritan Bennett, Inc.
Anesthesiology · 247d
Cleared Nov 14, 2003
BARD ENDOTRACHEAL TUBE, CUFFED
K030792 · BTR
C.R. Bard, Inc.
Anesthesiology · 247d
Cleared Nov 14, 2003
KWIKEZE MALE CONDOM APPLICATOR
K031007 · HIS
Condax, LLC
Obstetrics & Gynecology · 228d