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
31825–31848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 2016
ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set
K153652 · CAZ
Teleflex, Inc.
Anesthesiology · 183d
Cleared Jun 21, 2016
OEC Elite MiniView
K160131 · OXO
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 153d
Cleared Jun 21, 2016
Gold Anchor
K160209 · IYE
Naslund Medical AB
Radiology · 145d
Cleared Jun 21, 2016
s-Clean Tapered II RBM Implant System
K160213 · DZE
Dentis Co., Ltd.
Dental · 144d
Cleared Jun 21, 2016
Advanced Medical Imaging Software Suite (KSWVWR)
K160334 · LLZ
Keosys Sas
Radiology · 134d
Cleared Jun 21, 2016
Acne Light Therapy Wand
K160691 · OLP
Zuko, Inc.
General & Plastic Surgery · 102d
Cleared Jun 21, 2016
DBSWIN and VistaEasy Imaging Software
K161444 · LLZ
Duerr Dental AG
Radiology · 27d
Cleared Jun 20, 2016
RADspeed Pro
K152244 · KPR
Shimadzu Corporation
Radiology · 315d
Cleared Jun 20, 2016
DermaTherapy Bed Linens
K152884 · FMW
Precision Fabrics Group, Inc.
General Hospital · 264d
Cleared Jun 20, 2016
Lehman Manometry Catheter
K160170 · FFX
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 145d
Cleared Jun 20, 2016
V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...
K160451 · OMP
Kci USA, Inc. (Kinetic Concepts, Inc.)
General & Plastic Surgery · 123d
Cleared Jun 20, 2016
BI IMAGE-X EVOLUTION
K160458 · EHD
Radiotecnologia Industrial S.A. DE C.V.
Radiology · 122d
Cleared Jun 20, 2016
RCT700
K160525 · OAS
Ray Co., Ltd.
Radiology · 116d
Cleared Jun 20, 2016
REBOA Balloon Catheter
K160598 · MJN
NuMED, Inc.
Cardiovascular · 110d
Cleared Jun 20, 2016
Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical...
K161134 · GEI
Bovie Medical Corporation
General & Plastic Surgery · 59d
Cleared Jun 18, 2016
Kerrison Rongeurs
K152734 · HAE
Vitalitec Medizintechnik GmbH
Neurology · 270d
Cleared Jun 17, 2016
SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr...
K152771 · KNS
Sumitomo Bakelite Co., Ltd.
Gastroenterology & Urology · 266d
Cleared Jun 17, 2016
Quantib Brain 1
K153351 · LLZ
Quantib B.V.
Radiology · 210d
Cleared Jun 17, 2016
S698 Symbioz flow
K153367 · HIF
Sopro - Acteon Group
Obstetrics & Gynecology · 207d
Cleared Jun 17, 2016
CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE...
K153374 · HRS
Orthocare
Orthopedic · 207d
Cleared Jun 17, 2016
Sol-M Insulin Syringe, Sol-M TB Syringe
K153537 · FMF
Sol-Millennium Medical, Inc.
General Hospital · 190d
Cleared Jun 17, 2016
Image Navigator by Immuno Concepts
K160265 · DHN
Immuno Concepts, N.A. , Ltd.
Immunology · 136d
Cleared Jun 17, 2016
Withings Thermo (Model SCT01)
K160544 · FLL
Withings
General Hospital · 112d
Cleared Jun 17, 2016
CenterCross Ultra Catheter
K160681 · DQY
Roxwood Medical, Inc.
Cardiovascular · 99d