Search FDA 510(k) Database

7,095 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
20569–20592 of 174,061
Cleared Aug 13, 2019
Cartesion Prime
K191582 · KPS
Canon Medical Systems Corporation
Radiology · 60d
Cleared Aug 13, 2019
Instylla Microcatheter
K191731 · KRA
Instylla, Inc.
Cardiovascular · 46d
Cleared Aug 12, 2019
Critical Care Suite
K183182 · QFM
Ge Medical Systems, LLC
Radiology · 266d
Cleared Aug 12, 2019
Dr J Spinal and Epidural Needles
K183316 · BSP
Dr. Japan Co., Ltd.
Anesthesiology · 255d
Cleared Aug 12, 2019
EVOL® -SI Joint Fusion System
K190025 · OUR
Cutting Edge Spine, LLC
Orthopedic · 217d
Cleared Aug 12, 2019
Blue Sky Bio Zygomatic Implant System
K190491 · NHA
Blue Sky Bio, LLC
Dental · 165d
Cleared Aug 12, 2019
Cervical Spinal Truss System-Stand Alone (CSTS-SA)
K190870 · OVE
4Web, Inc.
Orthopedic · 131d
Cleared Aug 12, 2019
Arsenal Plating System
K191009 · HRS
Trilliant Surgical
Orthopedic · 118d
Cleared Aug 12, 2019
ATEC Lateral Interbody System
K191311 · MAX
Alphatec Spine, Inc.
Orthopedic · 89d
Cleared Aug 12, 2019
Facilis™ Spinal System
K191494 · NKB
Baui Biotech Co., Ltd.
Orthopedic · 68d
Cleared Aug 09, 2019
Bone Screw, Bone Tack
K182881 · DZL
Osstem Implant Co., Ltd.
Dental · 298d
Cleared Aug 09, 2019
NxStage Cartridge Express with Speedswap
K183158 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 267d
Cleared Aug 09, 2019
ELAN 4 Tools
K183203 · HBE
Aesculap, Inc.
Neurology · 263d
Cleared Aug 09, 2019
SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium...
K183647 · GEX
Olympus Surgical Technologies America
General & Plastic Surgery · 226d
Cleared Aug 09, 2019
Morpheus-C
K190371 · MQV
Biogennix, LLC
Orthopedic · 175d
Cleared Aug 09, 2019
Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys...
K191114 · PQK
Avenu Medical
Cardiovascular · 105d
Cleared Aug 09, 2019
ARIETTA 750
K191233 · IYN
Hitachi Healthcare Americas
Radiology · 93d
Cleared Aug 09, 2019
Turnpike Catheter
K191560 · DQY
Vascular Solutions, LLC
Cardiovascular · 57d
Cleared Aug 09, 2019
Versana Balance
K191792 · IYN
GE Medical Systems Ultrasound and...
Radiology · 37d
Cleared Aug 09, 2019
Versana Active
K191798 · IYN
GE Medical Systems Ultrasound and...
Radiology · 37d
Cleared Aug 09, 2019
DR 100s
K191884 · IZL
Agfa N.V.
Radiology · 25d
Cleared Aug 08, 2019
Transit-Pellets
K181760 · FFX
Medifactia AB
Gastroenterology & Urology · 401d
Cleared Aug 08, 2019
Conformity Stem
K183312 · LZO
United Orthopedic Corporation
Orthopedic · 252d
Cleared Aug 08, 2019
CoLink Plating System, Fracture and Correction System, RTS Implant System,...
K190385 · HRS
In2bones USA, LLC
Orthopedic · 170d