Search FDA 510(k) Database

7,042 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
19513–19536 of 174,061
Cleared Dec 17, 2019
ExSpiron 2Xi
K192595 · BZK
Respiratory Motion
Anesthesiology · 88d
Cleared Dec 17, 2019
Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology...
K192615 · FTM
Synovis Life Technologies, Inc....
General & Plastic Surgery · 85d
Cleared Dec 17, 2019
syngo.CT CaScoring
K192763 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 78d
Cleared Dec 17, 2019
Single Use Balloon Dilator V (with knife)
K193039 · KNS
Olympus Medical Systems Corp.
Gastroenterology & Urology · 47d
Cleared Dec 17, 2019
Bashir Plus Endovascular Catheter
K193071 · QEY
Thrombolex, Inc.
Cardiovascular · 43d
Cleared Dec 17, 2019
EV1000 Clinical Platform
K193179 · DXG
Edwards Lifesciences, LLC
Cardiovascular · 29d
Cleared Dec 17, 2019
G Surgical Marksman System
K193219 · NKB
G Surgical, LLC
Orthopedic · 26d
Cleared Dec 16, 2019
Pantheon Spinal Pontus Interbody Fusion Device
K181548 · MAX
Pantheon Spinal
Orthopedic · 552d
Cleared Dec 16, 2019
SunClear Aligner system
K190394 · NXC
Sun Dental Laboratories, LLC
Dental · 300d
Cleared Dec 16, 2019
Lawson Retrograde Nephrostomy Wire Puncture Set
K190903 · LJE
Cook Incorporated
Gastroenterology & Urology · 252d
Cleared Dec 16, 2019
Llis, Vittra APS
K191306 · EBF
Dentscare Ltda
Dental · 216d
Cleared Dec 16, 2019
EM Provisional
K191751 · DZE
Hiossen, Inc.
Dental · 168d
Cleared Dec 16, 2019
Stand-Alone ALIF Titanium System
K191834 · OVD
Life Spine, Inc.
Orthopedic · 160d
Cleared Dec 16, 2019
Deka Luxea
K192539 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 91d
Cleared Dec 16, 2019
CORRIDOR Fixation System
K192744 · MRW
Globus Medical, Inc.
Orthopedic · 77d
Cleared Dec 16, 2019
Physio Flex Annuloplasty Ring
K192762 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 77d
Cleared Dec 16, 2019
CEDIA Heroin Metabolite (6-AM) assay
K192943 · DJG
Microgenics Corporation
Toxicology · 59d
Cleared Dec 16, 2019
Keos Lumbar IBFD
K193174 · MAX
Keos
Orthopedic · 28d
Cleared Dec 15, 2019
AXS Vecta Aspiration Catheter
K190833 · DQY
Stryker Neurovascular
Neurology · 258d
Cleared Dec 14, 2019
Airlock Centrolock Osteosynthesis Implant System
K192356 · HRS
Novastep
Orthopedic · 107d
Cleared Dec 13, 2019
Corelink Navigation Instruments
K182731 · OLO
Corelink, LLC
Orthopedic · 441d
Cleared Dec 13, 2019
Ambar, Ambar APS, Ambar Universal APS
K183424 · KLE
Dentscare Ltda
Dental · 367d
Cleared Dec 13, 2019
EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor...
K190715 · ERL
Interscope, Inc.
Ear, Nose, Throat · 269d
Cleared Dec 13, 2019
Infrared Thermometer, model: PC808
K190717 · FLL
Shenzhen Pacom Medical Instruments...
General Hospital · 268d