Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
53761–53784 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 21, 2009
MECC SET WITH BIOLINE COATING
K083794 · KFM
Maquet Cardiopulmonary, AG
Cardiovascular · 120d
Cleared Apr 21, 2009
CHEMPAQ XBC ANALYZER
K090013 · GKZ
Chempaq A/S
Hematology · 109d
Cleared Apr 21, 2009
INTRAVENOUS POWER INJECTOR EXTENSION SET
K090134 · FPA
C.R. Bard, Inc.
General Hospital · 90d
Cleared Apr 21, 2009
NOVATION CFS PRESS-FIT AND CEMENTED STEMS
K090764 · LWJ
Exactech, Inc.
Orthopedic · 29d
Cleared Apr 21, 2009
MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM
K090872 · FZP
Cardica, Inc.
General & Plastic Surgery · 22d
Cleared Apr 21, 2009
WELL-PASTE
K090992 · KIF
Vericom Co., Ltd.
Dental · 14d
Cleared Apr 20, 2009
CALIX SPINAL IMPLANT SYSTEM
K083637 · ODP
X-Spine Systems, Inc.
Orthopedic · 132d
Cleared Apr 20, 2009
LANX FUSION SYSTEM
K083815 · MAX
Lanx, Inc.
Orthopedic · 119d
Cleared Apr 20, 2009
PARADIS VASO SHIELD
K090022 · OMR
Spinemedica, LLC
Cardiovascular · 105d
Cleared Apr 20, 2009
ATLAS IMPLANT SYSTEM- MINI PLUS
K090049 · DZE
Cowellmedi Co., Ltd.
Dental · 103d
Cleared Apr 20, 2009
MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114
K090506 · HBL
Integra LifeSciences Corporation
Neurology · 54d
Cleared Apr 20, 2009
MODIFICATION TO: S4 SPINAL SYSTEM
K090657 · NKB
Aesculap Implant Systems
Orthopedic · 39d
Cleared Apr 20, 2009
NIO COLOR 3MP AND MDNC-3121
K090732 · LLZ
Barco N.V.
Radiology · 32d
Cleared Apr 20, 2009
MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
K090814 · FAJ
Gyrus Acmi, Inc.
Gastroenterology & Urology · 26d
Cleared Apr 17, 2009
CAPILLARYS IMMUNOTYPING, MODEL 2100
K082085 · CFF
Sebia
Immunology · 268d
Cleared Apr 17, 2009
LATARJET CORTICAL SCREW SET
K083096 · HWC
Tag Medical Products
Orthopedic · 182d
Cleared Apr 17, 2009
ISKRA MEDICAL GREEN IRF PRESTIGE
K083590 · GEI
Iskra Medical, D.O.O.
General & Plastic Surgery · 134d
Cleared Apr 17, 2009
TERUMO PALL AL6X ARTERIAL FILTER
K083834 · DTM
Terumo Cardiovascular Systems Corp.
Cardiovascular · 115d
Cleared Apr 17, 2009
HG II FIXTURE SYSTEM
K090237 · DZE
Hiossen, Inc.
Dental · 74d
Cleared Apr 17, 2009
VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM
K090679 · MVR
Vioptix, Inc.
General & Plastic Surgery · 32d
Cleared Apr 17, 2009
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K090714 · KWP
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Apr 16, 2009
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
K081922 · JLX
Wallac OY
Chemistry · 283d
Cleared CT Apr 16, 2009
IMPELLA 5.0 CATHETER FAMILY
K083111 · KFM
Abiomed, Inc.
Cardiovascular · 177d
Cleared Apr 16, 2009
RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20...
K083223 · LFR
Abbott Diabetes Care, Inc.
Chemistry · 164d