Search FDA 510(k) Database

6,485 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
8905–8928 of 174,061
Cleared Jun 16, 2023
Volumat Polyethylene I.V. Administration Set
K221121 · FPA
Fresenius Kabi
General Hospital · 424d
Cleared Jun 16, 2023
The iNAP One Sleep Therapy System
K220907 · OZR
Somnics, Inc.
Anesthesiology · 444d
Cleared Jun 16, 2023
F&P 950 Respiratory Humidifier
K220703 · BTT
Fisher & Paykel Healthcare
Anesthesiology · 463d
Cleared Jun 16, 2023
Mindray SV600 Ventilator, Mindray SV800 Ventilator
K220107 · CBK
Shenzhen Mindray Bio-Medical...
Anesthesiology · 520d
Cleared Jun 15, 2023
Xerxes Hip Stem
K231109 · LZO
Xerxes Arthopedix, LLC
Orthopedic · 57d
Cleared Jun 15, 2023
Zevo Anterior Cervical Plate System
K231090 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 59d
Cleared Jun 15, 2023
ERBEJET® 2 System
K231023 · FQH
Erbe Elektromedizin GmbH
General & Plastic Surgery · 65d
Cleared Jun 15, 2023
EDEN Spinal Fixation MIS System
K230762 · NKB
Jmt Co., Ltd.
Orthopedic · 87d
Cleared Jun 15, 2023
UTC 3mL Medication Cartridge
K230718 · MRZ
Gilero, LLC
General Hospital · 92d
Cleared Jun 15, 2023
IPL Hair Removal Device Models: MLY-T069
K230473 · OHT
Miley Technology (Hebei) Co., Ltd.
General & Plastic Surgery · 113d
Cleared Jun 15, 2023
SpassageQ
K230386 · PLB
Spass, Inc.
Cardiovascular · 121d
Cleared Jun 15, 2023
Celerity 5 HP Biological Indicator
K223717 · FRC
STERIS Corporation
General Hospital · 185d
Cleared Jun 15, 2023
Celerity Incubator
K223715 · FRC
STERIS Corporation
General Hospital · 195d
Cleared Jun 15, 2023
WallFlex™ Biliary RX Stent System
K223469 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 210d
Cleared Jun 15, 2023
TNI Clear-Guard™ 3 angled breathing filter (1545020)
K223258 · CAH
Intersurgical , Ltd.
General Hospital · 237d
Cleared Jun 15, 2023
EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus...
K222861 · EOQ
Olympus Medical Systems Corporation
Ear, Nose, Throat · 266d
Cleared Jun 14, 2023
ClearumTM HS
K231406 · KDI
Bellco Srl
Gastroenterology & Urology · 30d
Cleared Jun 14, 2023
TRIGEN META-NAIL Nail System
K230761 · JDS
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Jun 14, 2023
Zavation ALIF System
K230731 · OVD
Zavation Medical Products, LLC
Orthopedic · 90d
Cleared Jun 14, 2023
Single-use Flexible Rhinolaryngoscope
K230536 · EOB
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 107d
Cleared Jun 14, 2023
Electronic Blood Pressure Monitor
K223291 · DXN
Shenzhen Pango Medical Electronics...
Cardiovascular · 231d
Cleared Jun 14, 2023
Niti-S Duodenal Stent
K223067 · MUM
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 264d
Cleared Jun 14, 2023
VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus...
K222822 · BZE
Draegerwerk AG & CO Kgaa
Anesthesiology · 268d
Cleared Jun 14, 2023
F65 Laser System
K222790 · OAP
Lumenis Be, Ltd.
General & Plastic Surgery · 272d