Search FDA 510(k) Database

7,159 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
22513–22536 of 174,061
Cleared Dec 06, 2018
Simplicit90Y
K182016 · LLZ
Mirada Medical, Ltd.
Radiology · 132d
Cleared Dec 06, 2018
FFRct
K182035 · PJA
HeartFlow, Inc.
Cardiovascular · 129d
Cleared Dec 06, 2018
EVOLUTION Stemmed CS Femur
K182125 · JWH
Microport Orthopedics, Inc.
Orthopedic · 122d
Cleared Dec 06, 2018
PowerLook Tomo Detection V2 Software
K182373 · QDQ
Icad, Inc.
Radiology · 97d
Cleared Dec 06, 2018
Synthetic Polyisoprene Lubricated Male Condom - 5 senses
K182438 · MOL
Sxwell USA, LLC
Obstetrics & Gynecology · 90d
Cleared Dec 06, 2018
KerraContact Ag Perf Advanced Perforated Silver Wound Dressing
K182680 · FRO
Exciton Technologies, Inc.
General & Plastic Surgery · 71d
Cleared Dec 06, 2018
IntelliSpace Radiology
K182926 · LLZ
Philips Healthcare Informatics, Inc.
Radiology · 45d
Cleared Dec 06, 2018
Zenition 70
K183040 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 35d
Cleared Dec 06, 2018
Senhance Surgical System
K183098 · NAY
Transenterix, Inc.
General & Plastic Surgery · 29d
Cleared Dec 06, 2018
Unity Network ID
K183116 · MWI
Ge Healthcare
Cardiovascular · 27d
Cleared Dec 04, 2018
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer...
K180615 · LKN
Fresenius Kabi USA,Llc
Gastroenterology & Urology · 271d
Cleared Dec 04, 2018
Spartan eCoil System
K180653 · HCG
Spartan Micro, Inc.
Neurology · 266d
Cleared Dec 04, 2018
HS50 / HS60 Diagnostic Ultrasound System
K181336 · IYN
Samsung Medison Co., Ltd.
Radiology · 197d
Cleared Dec 04, 2018
CAAS MR Solutions
K181825 · LLZ
Pie Medical Imaging BV
Radiology · 148d
Cleared Dec 04, 2018
Endoform Reconstructive Template - Non Absorbable
K181935 · FTL
Aroa Biosurgery , Ltd.
General & Plastic Surgery · 138d
Cleared Dec 04, 2018
MectaLIF Posterior Extension
K181970 · MAX
Medacta International S.A.
Orthopedic · 133d
Cleared Dec 04, 2018
Elekta Unity
K182076 · IYE
Elekta Limited
Radiology · 125d
Cleared Dec 04, 2018
NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture...
K182479 · DHB
Hycor Biomedical
Immunology · 85d
Cleared Dec 04, 2018
Healix™ Compression Screw System
K182949 · HWC
Nvision Biomedical Technologies, LLC
Orthopedic · 42d
Cleared Dec 04, 2018
MOSAIQ Oncology Information System
K183034 · IYE
Elekta, Inc.
Radiology · 33d
Cleared Dec 04, 2018
Monaco RTP System
K183037 · MUJ
Elekta, Inc.
Radiology · 33d
Cleared Dec 04, 2018
Coolrail Linear Pen
K183065 · OCL
AtriCure, Inc.
Cardiovascular · 29d
Cleared Dec 04, 2018
NobelZygoma 0°
K183069 · DZE
Nobel Biocare AB
Dental · 29d
Cleared Dec 04, 2018
6420 Ultrasound System
K183191 · IYN
Esaote, S.P.A.
Radiology · 15d