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
37729–37752 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 07, 2014
VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION
K133784 · ODP
Zimmer Trabecular Metal Technology
Orthopedic · 207d
Cleared Jul 07, 2014
RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL
K140324 · MBI
Depuy Mitek, A Johnson and Johnson...
Orthopedic · 147d
Cleared Jul 07, 2014
PULSE OXIMETER
K140785 · DQA
Nonin Medical, Inc.
Anesthesiology · 98d
Cleared Jul 07, 2014
VECTORFLOW
K141051 · MSD
Arrow International, Inc.
Gastroenterology & Urology · 74d
Cleared Jul 07, 2014
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL...
K141432 · DTN
Maquet Cardiopulmonary, AG
Cardiovascular · 38d
Cleared Jul 03, 2014
NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS
K131923 · GZI
Techlink International
Neurology · 372d
Cleared Jul 03, 2014
INFANT INCUBATOR
K132543 · FMZ
Bistos Co., Ltd.
General Hospital · 324d
Cleared Jul 03, 2014
Z5C
K132881 · DZE
Z-Systems AG
Dental · 293d
Cleared Jul 03, 2014
COBRA FUNDUS CAMERA
K132987 · HKI
C.S.O. S.R.L.
Ophthalmic · 282d
Cleared Jul 03, 2014
MICROPUNCTURE INTRODUCER SET
K133114 · DYB
Cook Incorporated
Cardiovascular · 276d
Cleared Jul 03, 2014
H&H EMERGENCY CRICOTHYROTOMY KIT
K133528 · JOH
H & H Medical Corporation
Anesthesiology · 230d
Cleared Jul 03, 2014
POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK
K133689 · LZA
Pt. Medisafe Technologies
General Hospital · 213d
Cleared Jul 03, 2014
ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM
K133835 · HTN
Arthrosurface, Inc.
Orthopedic · 197d
Cleared Jul 03, 2014
LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
K140141 · NBW
Ceragem Medisys, Inc.
Chemistry · 162d
Cleared Jul 03, 2014
EDWARDS TRANSFEMORAL BALLOON CATHETER
K140241 · OZT
Edwards Lifesciences, LLC
Cardiovascular · 154d
Cleared Jul 03, 2014
ASCEND
K140333 · NUH
Neurometrix, Inc.
Neurology · 143d
Cleared Jul 03, 2014
VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA
K140641 · DYB
Boston Scientific Corporation
Cardiovascular · 113d
Cleared Jul 03, 2014
POROUS COATED COMPREHENSIVE FRACTURE STEMS
K140652 · PHX
Biomet Manufacturing Corp
Orthopedic · 111d
Cleared Jul 03, 2014
DCAS I
K140869 · LLZ
Gp&P Co., Ltd.
Radiology · 91d
Cleared Jul 03, 2014
E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1...
K140902 · JWH
Biomet, Inc.
Orthopedic · 85d
Cleared Jul 03, 2014
NORMED VARIO SUBTALAR SCREW
K140962 · HWC
Normed Nedizin Technik GmbH
Orthopedic · 79d
Cleared Jul 03, 2014
POD SYSTEM
K141134 · HCG
Penumbra, Inc.
Neurology · 63d
Cleared Jul 02, 2014
U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA
K132384 · HIH
Endosec Corporation
Obstetrics & Gynecology · 336d
Cleared Jul 02, 2014
EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM
K133110 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 275d