FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
9793–9816 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 2023
DeepCatch
K223556 · QIH
Medical IP Co., Ltd.
Radiology · 200d
Cleared Jun 16, 2023
EyeArt v2.2.0
K223357 · PIB
Eyenuk, Inc.
Ophthalmic · 226d
Cleared Jun 16, 2023
Zynex Monitoring System, Model CM-1600
K223217 · DSB
Zynex Medical, Inc.
Cardiovascular · 242d
Cleared Jun 16, 2023
Surgical Gown
K222999 · FYA
Hubei Woozon Healthcare Co., Ltd.
General Hospital · 261d
Cleared Jun 16, 2023
Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421
K222906 · MMK
Ningbo Maxcon Medical Technology Co.,...
General Hospital · 266d
Cleared Jun 16, 2023
BabySat 3
K222597 · DQA
Owlet Babycare, Inc.
Anesthesiology · 291d
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