Search FDA 510(k) Database

7,152 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
22057–22080 of 174,061
Cleared Feb 01, 2019
Glo-Tip Spray Catheter
K182319 · OCX
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 158d
Cleared Feb 01, 2019
HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High
K182744 · GGM
Eurotrol B.V.
Hematology · 126d
Cleared Feb 01, 2019
Endoscope Sterilization Tray
K183139 · KCT
Intuitive Surgical, Inc.
General Hospital · 80d
Cleared Feb 01, 2019
AI Rad Companion (Engine)
K183272 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 70d
Cleared Feb 01, 2019
DR 800 with Tomosynthesis
K183275 · IZF
Agfa N.V.
Radiology · 70d
Cleared Feb 01, 2019
Supria True64 Whole-Body X-Ray CT System
K183291 · JAK
Hitachi Healthcare Americas
Radiology · 67d
Cleared Feb 01, 2019
Vbeam Prima Laser System
K183452 · GEX
Candela Corp.
General & Plastic Surgery · 50d
Cleared Feb 01, 2019
SECULOK™ ACP System
K190053 · KWQ
U&I Corporation
Orthopedic · 21d
Cleared Jan 31, 2019
STRONG Dental Handpieces
K181129 · EGS
Saeshin Precision Co., Ltd.
Dental · 276d
Cleared Jan 31, 2019
Panoura X-ERA PF/NF/MF
K182198 · MUH
The Yoshida Dental Mfg. Co., Ltd.
Radiology · 170d
Cleared Jan 31, 2019
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900
K182827 · MED
STERIS Corporation
General Hospital · 118d
Cleared Jan 31, 2019
Endosee System
K183020 · HIH
CooperSurgical, Inc.
Obstetrics & Gynecology · 91d
Cleared Jan 30, 2019
Patient Cables and Leadwires , Disposable ECG Leadwires
K182327 · DSA
Orantech, Inc.
Cardiovascular · 156d
Cleared Jan 30, 2019
Boston Keratoprosthesis, Type I Lucia
K182986 · HQM
Massachusetts Eye and Ear Infirmary...
Ophthalmic · 93d
Cleared Jan 30, 2019
MOTO Partial Knee System
K183029 · HSX
Medacta International S.A.
Orthopedic · 90d
Cleared Jan 30, 2019
Zimmer Segmental System Proximal Femoral Component
K183136 · LZO
Zimmer, Inc.
Orthopedic · 78d
Cleared Jan 30, 2019
Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid
K183696 · PHX
Tornier, Inc.
Orthopedic · 30d
Cleared Jan 29, 2019
Neo Cage System TM
K181048 · MAX
Neo Medical SA
Orthopedic · 285d
Cleared Jan 29, 2019
Cortex CAD/CAM Abutments
K181580 · NHA
Cortex Dental Implants Industries , Ltd.
Dental · 228d
Cleared Jan 29, 2019
T-PLUS
K181893 · PBX
Wintecare SA
General & Plastic Surgery · 200d
Cleared Jan 29, 2019
AQrate Robotic Assistance System
K182000 · HAW
Globus Medical, Inc.
Orthopedic · 187d
Cleared Jan 29, 2019
FastPack IP Sex Hormone Binding Globulin Immunoassay
K182521 · CDZ
Qualigen, Inc.
Chemistry · 138d
Cleared Jan 29, 2019
X5 Series Digital Color Doppler Ultrasound System
K182648 · IYN
Sonoscape Medical Corp.
Radiology · 127d
Cleared Jan 29, 2019
Solitaire 4 Revascularization Device
K183022 · POL
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 89d