Search FDA 510(k) Database

7,158 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
22417–22440 of 174,061
Cleared Dec 14, 2018
SureClip Repositionable Hemostasis Clip
K182556 · PKL
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 88d
Cleared Dec 14, 2018
Vitrea Software Package, VSTP-001A
K182601 · LLZ
Canon Medical Systems Corporation
Radiology · 84d
Cleared Dec 14, 2018
Rapid Reboot Compression Therapy System
K182668 · IRP
Rapid Reboot Recovery Products, LLC
Physical Medicine · 80d
Cleared Dec 14, 2018
AC5 Topical Gel
K182681 · FRO
Arch Therapeutics, Inc.
General & Plastic Surgery · 79d
Cleared Dec 14, 2018
Cardio-TriTest v6.5
K182790 · DPS
Cardio-Phoenix, Inc.
Cardiovascular · 74d
Cleared Dec 14, 2018
RCT800
K182805 · OAS
Ray Co., Ltd.
Radiology · 73d
Cleared Dec 14, 2018
3880 MRI Patient Monitoring System
K182900 · MWI
Iradimed Corporation
Cardiovascular · 59d
Cleared Dec 14, 2018
UniPulse
K182905 · DRL
Seaward Group
Cardiovascular · 59d
Cleared Dec 14, 2018
MTS Omadacycline 0.002-32 µg/mL
K182922 · JWY
Liofilchem S. R. L.
Microbiology · 56d
Cleared Dec 14, 2018
Affixus Hip Fracture Nail
K183162 · HSB
Biomet, Inc.
Orthopedic · 29d
Cleared Dec 13, 2018
BTL-FR2000
K180359 · GEI
BTL Industries, Inc.
General & Plastic Surgery · 307d
Cleared Dec 13, 2018
PYRAMIDION Dental Implants and Prostheses
K180859 · DZE
Dentack Implants, Ltd.
Dental · 255d
Cleared Dec 13, 2018
Accu-Chek Guide Me Blood Glucose Monitoring System
K181131 · NBW
Roche Diabetes Care
Chemistry · 227d
Cleared Dec 13, 2018
Argos
K181372 · DXG
Retia Medical, LLC
Cardiovascular · 204d
Cleared Dec 13, 2018
DuraSheath Introducer Sheath System
K181463 · DYB
Contract Medical International, GmbH
Cardiovascular · 192d
Cleared Dec 13, 2018
CBT Screw Fixation System
K181824 · NKB
U&I Corporation
Orthopedic · 157d
Cleared Dec 13, 2018
ROCCIA® PLIF
K181899 · MAX
Silony Medical GmbH
Orthopedic · 150d
Cleared Dec 13, 2018
EVOLUX CAD/CAM PMMA BLOCKS
K182065 · EBG
Blue Dent Dental
Dental · 134d
Cleared Dec 13, 2018
Erran Dental Zirconia
K182068 · EIH
Hangzhou Erran Technology Co., Ltd.
Dental · 134d
Cleared Dec 13, 2018
neoBLUE blanket LED Phototherapy System
K182178 · LBI
Natus Medical Incorporated
General Hospital · 122d
Cleared Dec 13, 2018
HipCheck
K182359 · LLZ
Stryker Corp.
Radiology · 105d
Cleared Dec 13, 2018
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
K182397 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 100d
Cleared Dec 13, 2018
LaparoGuard
K182434 · GCJ
Mariner Endosurgery, Inc.
General & Plastic Surgery · 98d
Cleared Dec 13, 2018
StatStrip Xpress 2 Glucose Hospital Meter System
K182549 · PZI
Nova Biomedical Corporation
Chemistry · 87d