FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Anesthesiology ×
9,002 results
265–288 of 9,002
Search insights Median review: 93d Cleared: 100% Top manufacturer: Respironics, Inc. Lead specialty: Anesthesiology
Cleared Aug 02, 2024
Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
K241268 · BZE
Exceleron Medical
Anesthesiology · 88d
Cleared Jul 31, 2024
AF531 Oro-Nasal EE Leak 1 Face Mask
K233555 · BZD
Philips Respironics
Anesthesiology · 268d
Cleared Jul 26, 2024
“LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System...
K233501 · MNR
Largan Medical Co., Ltd.
Anesthesiology · 269d
Cleared Jul 15, 2024
Huxley SANSA Home Sleep Apnea Test (1000-00)
K240285 · MNR
Huxley Medical
Anesthesiology · 165d
Cleared Jul 10, 2024
Mojo 2 Full Face Vented Mask
K241661 · BZD
Sleepnet Corporation
Anesthesiology · 30d
Cleared Jul 02, 2024
Tyto Insights for Crackles Detection
K240555 · PHZ
Tyto Care , Ltd.
Anesthesiology · 125d
Cleared Jul 02, 2024
DELTAWAVE Nasal Pillows System
K233415 · BZD
Remsleep Holdings
Anesthesiology · 266d
Cleared Jul 01, 2024
Pulse Oximeter (AOJ-70A)
K232989 · DQA
Shenzhen AOJ Medical Technology Co.,...
Anesthesiology · 283d
Cleared Jun 27, 2024
Mojo 2 Full Face Non-Vented Mask
K241520 · CBK
Sleepnet Corporation
Anesthesiology · 29d
Cleared Jun 21, 2024
Pulse Oximeter (MD300C228)
K232975 · DQA
Beijing Choice Electronic Technology...
Anesthesiology · 274d
Cleared Jun 18, 2024
MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter
K233553 · CAF
Thayer Medical Corporation
Anesthesiology · 225d
Cleared Jun 15, 2024
iQ 2 Nasal Vented Mask
K241469 · BZD
Sleepnet Corporation
Anesthesiology · 22d
Cleared Jun 14, 2024
HFT150
K233707 · BTT
Invent Medical Corporation
Anesthesiology · 207d
Cleared Jun 13, 2024
F&P Optiflow Oxygen Kit (AA451J)
K233821 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 195d
Cleared Jun 04, 2024
SAM Model 9-10000
K240100 · MNR
Snap Diagnostics, LLC
Anesthesiology · 144d
Cleared Jun 04, 2024
Hudson RCI Dri-Tech Breathing Circuits
K234032 · BZE
Medline Industries, LP
Anesthesiology · 167d
Cleared May 31, 2024
BroncTru™ Transbronchial Access Tool
K232601 · EOQ
Broncus Medical, Inc.
Anesthesiology · 277d
Cleared May 28, 2024
EVOLVE Nitric Oxide Delivery System
K240410 · MRN
Malinckrodt Manufacturing, LLC
Anesthesiology · 106d
Cleared May 23, 2024
NOxBOXi Nitric Oxide Delivery System
K233251 · MRN
Linde Gas & Equipment, Inc.
Anesthesiology · 238d
Cleared May 20, 2024
Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430,...
K233341 · BTR
Covidien, LLC
Anesthesiology · 234d
Cleared May 20, 2024
AViTA Pulse Oximeter
K223399 · DQA
Avita Corporation
Anesthesiology · 558d
Cleared May 17, 2024
Sentec Digital Monitoring System (SDMS) tCOM+
K232516 · LKD
Sentec AG
Anesthesiology · 273d
Cleared May 16, 2024
Sempulse Halo Vital Signs Monitor
K232495 · DQA
Sempulse Corporation
Anesthesiology · 273d
Cleared May 13, 2024
Disposable Double Lumen Endobronchial Tube
K232529 · CBI
Shenzhen Insighters Medical...
Anesthesiology · 266d