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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
46345–46368 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 2011
DESARA MESH
K112609 · OTN
Caldera Medical, Inc.
Gastroenterology & Urology · 22d
Cleared Sep 30, 2011
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE
K112738 · NBW
Andon Medical Co., Ltd.
Chemistry · 10d
Cleared Sep 29, 2011
MV INTRADERMIC NEEDLES
K110606 · FMI
M.V.S.R.L.
General Hospital · 210d
Cleared Sep 29, 2011
SCEPTER C OCCLUSION BALLOON CATHETER
K110741 · MJN
MicroVention, Inc.
Cardiovascular · 197d
Cleared Sep 29, 2011
MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM
K111350 · ONF
Medicam, Inc.
General & Plastic Surgery · 139d
Cleared Sep 29, 2011
TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX...
K111351 · FPA
Us Infusion Dba Truecare Biomedix
General Hospital · 139d
Cleared Sep 29, 2011
X12 STERILE REFLECTIVE MARKER SPHERE
K111443 · OLO
Pinsco Inc. Dba B & L Engineering
Orthopedic · 128d
Cleared Sep 29, 2011
CHARTIS CATHETER MODEL CHR-CA-12.0
K111522 · CBI
Pulmonx, Inc.
Anesthesiology · 119d
Cleared Sep 29, 2011
MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR
K111570 · CAF
Thayer Medical Corporation
Anesthesiology · 115d
Cleared Sep 29, 2011
EMG SYSTEM
K111687 · HCC
Myotronics-Noromed, Inc.
Neurology · 105d
Cleared Sep 29, 2011
EQUIMATRIX
K111816 · NPM
Luitpold Pharmaceuticals, Inc.
Dental · 94d
Cleared Sep 29, 2011
PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID
K111832 · EBI
Heraeus Kulzer, LLC
Dental · 93d
Cleared Sep 29, 2011
PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES
K111878 · KGO
Cardinal Health, Inc.
General Hospital · 90d
Cleared Sep 29, 2011
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
K111916 · HSX
Conformis, Inc.
Orthopedic · 85d
Cleared Sep 29, 2011
AGILLS PF DELIVERY SYSTEM
K111943 · DYB
St. Jude Medical, Cardiac Rhythm...
Cardiovascular · 83d
Cleared Sep 29, 2011
NEODYNE DRESSING
K112131 · MDA
Neodyne Biosciences, Inc.
General & Plastic Surgery · 65d
Cleared Sep 29, 2011
TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE
K112136 · KKX
Kunshan Jiehong Nonwoven Product Co.,...
General Hospital · 65d
Cleared Sep 29, 2011
HYDROCOIL EMBOLIC SYSTEM (HES)
K112226 · HCG
MicroVention, Inc.
Neurology · 57d
Cleared Sep 29, 2011
BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION
K112434 · KNT
Bd Medical Surgical
Gastroenterology & Urology · 36d
Cleared Sep 29, 2011
D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS
K112525 · DTM
Parexel International
Cardiovascular · 29d
Cleared Sep 29, 2011
5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT,...
K112584 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 23d
Cleared Sep 28, 2011
LITE-MED LM-9200 ELMA
K103217 · LNS
Lite-Med, Inc.
Gastroenterology & Urology · 331d
Cleared Sep 28, 2011
AURIGA XL
K111475 · GEX
Starmedtec GmbH
General & Plastic Surgery · 124d
Cleared Sep 28, 2011
SPINEFRONTIER LUMBAR IBF SYSTEM
K111553 · MAX
Spinefrontier, Inc.
Orthopedic · 117d