Search FDA 510(k) Database

6,973 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: Cleared only ×
174,061 results
18337–18360 of 174,061
Cleared May 08, 2020
Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate
K192209 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 268d
Cleared May 08, 2020
Custom Legacy and Custom InterActive Titanium Abutments
K192218 · NHA
Implant Direct Sybron Manufacturing, LLC
Dental · 267d
Cleared May 08, 2020
PRECICE Bone Transport System
K193016 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 192d
Cleared May 08, 2020
Precice® Screws
K193617 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 134d
Cleared May 08, 2020
Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
K200348 · PLV
Neocis, Inc.
Dental · 86d
Cleared May 08, 2020
ALTAPORE SHAPE
K200640 · MQV
Baxter Healthcare Corporation
Orthopedic · 58d
Cleared May 08, 2020
Mazor X
K200935 · OLO
Mazor Robotics , Ltd.
Orthopedic · 30d
Cleared May 08, 2020
Ventricular Catheter
K200950 · JXG
Aesculap, Inc.
Neurology · 29d
Cleared May 08, 2020
Treace Medical Concepts (TMC) Plating System
K200961 · HRS
Treace Medical Concepts, Inc.
Orthopedic · 28d
Cleared May 08, 2020
Sonosite PX Ultrasound System
K200964 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 28d
Cleared May 07, 2020
Actreen Hi-Lite Intermittent Urinary Catheters
K192577 · GBM
B.Braun Medical, Inc.
Gastroenterology & Urology · 231d
Cleared May 07, 2020
ZAGA Zygomatic System
K192651 · DZE
Southern Implants (Pty), Ltd.
Dental · 226d
Cleared May 07, 2020
Nuvo Nano Portable Oxygen Concentrator
K192693 · CAW
Nidek Medical Products, Inc.
Anesthesiology · 224d
Cleared May 07, 2020
Chemfort CSTD
K192866 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 213d
Cleared May 07, 2020
Patient Monitor
K192972 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 196d
Cleared May 07, 2020
EZER, Portable X-ray System
K193535 · IZL
Livermoretech, Inc.
Radiology · 139d
Cleared May 07, 2020
LiteSaber Wire Torque Assist Device
K200120 · DQX
Vesatek, LLC
Cardiovascular · 107d
Cleared May 07, 2020
HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor
K200146 · GEI
Covidien, LLC
General & Plastic Surgery · 106d
Cleared May 07, 2020
LOSPA II Knee System (EXULT Knee Replacement System)
K200395 · JWH
Corentec Co., Ltd.
Orthopedic · 79d
Cleared May 07, 2020
Catalyst+, Catalyst+ HD
K200435 · IYE
C-Rad Positioning AB
Radiology · 73d
Cleared May 07, 2020
ETEST Plazomicin (PLZ) (0.016-256 µg/mL)
K200512 · JWY
Biom?rieux SA
Microbiology · 66d
Cleared May 07, 2020
AMF Revision TT Cones
K200653 · JWH
Lima Corporate S.P.A.
Orthopedic · 56d
Cleared May 07, 2020
HS70A Diagnostic Ultrasound System
K200699 · IYN
Samsung Medison Co., Ltd.
Radiology · 51d
Cleared May 07, 2020
Icare HOME Tonometer
K200966 · HKY
Icare Finland OY
Ophthalmic · 27d