Search FDA 510(k) Database

7,000 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
18769–18792 of 174,061
Cleared Mar 20, 2020
ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
K193183 · OBJ
Acist Medical Systems, Inc.
Cardiovascular · 123d
Cleared Mar 20, 2020
Nano FortiFix® System
K193211 · NKB
Nanovis Spine, LLC
Orthopedic · 120d
Cleared Mar 20, 2020
Hepatic VCAR
K193281 · JAK
GE Medical Systems SCS
Radiology · 114d
Cleared Mar 20, 2020
Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health...
K193327 · FYA
Cardinal Health200, LLC
General Hospital · 109d
Cleared Mar 20, 2020
T2 ICF
K193366 · HWC
Stryker GmbH
Orthopedic · 107d
Cleared Mar 20, 2020
Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder...
K193560 · QHE
Materialise NV
Orthopedic · 88d
Cleared Mar 20, 2020
Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy...
K193581 · LZA
Sri Trang Gloves (Thailand) Public...
General Hospital · 88d
Cleared Mar 20, 2020
Q Switched Nd: YAG Laser machine
K193609 · GEX
Beijing Lead Beauty S & T Co., Ltd.
General & Plastic Surgery · 85d
Cleared Mar 20, 2020
iTero Element 5D
K193659 · NTK
Align Technology, Inc.
Dental · 81d
Cleared Mar 20, 2020
AI-ECG Tracker
K200036 · DPS
Shenzhen Carewell Electronics Co., Ltd.
Cardiovascular · 72d
Cleared Mar 20, 2020
MTS Omadacycline 0.002 - 32 ug/mL
K200180 · JWY
Liofilchem S. R. L.
Microbiology · 56d
Cleared Mar 20, 2020
Symbia 6.7
K200474 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 23d
Cleared Mar 19, 2020
Park's Pectus System
K191057 · HRS
Tdm Co., Ltd.
Orthopedic · 332d
Cleared Mar 19, 2020
IV Sets not made with PVC
K191658 · FPA
B.Braun Medical, Inc.
General Hospital · 272d
Cleared Mar 19, 2020
F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)
K191818 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 258d
Cleared Mar 19, 2020
Compression Therapy Device
K191856 · JOW
Guangzhou Longest Science &...
Cardiovascular · 252d
Cleared Mar 19, 2020
Creo Electrosurgical System with HS1 Hemostasis Accessory
K192905 · KNS
Creo Medical, Ltd.
Gastroenterology & Urology · 156d
Cleared Mar 19, 2020
G1 40 Radiopaque Bone Cement
K193059 · LOD
G21, S.R.L.
Orthopedic · 139d
Cleared Mar 19, 2020
G3 40 Radiopaque Bone Cement
K193061 · LOD
G21, S.R.L.
Orthopedic · 139d
Cleared Mar 19, 2020
restor3d Metallic Interference Screw
K193491 · HWC
Restor3d
Orthopedic · 93d
Cleared Mar 19, 2020
Deklene MAXX
K193530 · GAW
Teleflex Medical
General & Plastic Surgery · 90d
Cleared Mar 19, 2020
Super Sheath
K200379 · DRE
Togo Medikit Co., Ltd.
Cardiovascular · 30d
Cleared Mar 18, 2020
Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
K191027 · BSZ
Maquet Critical Care AB
Anesthesiology · 335d
Cleared Mar 18, 2020
PulmoScan
K191876 · PNV
Cognita Labs, LLC
Anesthesiology · 247d