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
505–528 of 9,002
Search insights Median review: 93d Cleared: 100% Top manufacturer: Respironics, Inc. Lead specialty: Anesthesiology
Cleared Jan 10, 2022
iQ 2 Nasal Mask, Phantom 2 Nasal Mask
K211274 · BZD
Sleepnet Corporation
Anesthesiology · 258d
Not Cleared Jan 07, 2022
Sunrise Sleep Disorder Diagnostic Aid
DEN210015 · QRS
Sunrise
Anesthesiology · 280d
Cleared Jan 06, 2022
Enlight 2100
K211135 · QEB
Timpel S.A.
Anesthesiology · 265d
Cleared Dec 29, 2021
Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE...
K213316 · KOI
Nihon Kohden Corporation
Anesthesiology · 86d
Cleared Dec 23, 2021
Altech® Exhalation Valve (Single Limb and Dual Limb)
K210992 · CBP
Meditera Tibbi Malzeme San VE Tic AS
Anesthesiology · 265d
Cleared Dec 22, 2021
BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle
K210978 · BSP
Becton, Dickinson and Company
Anesthesiology · 265d
Cleared Dec 22, 2021
Pulse Oximeter
K210305 · DQA
Dongguan Lingxin Technologies Co., Ltd.
Anesthesiology · 322d
Cleared Dec 21, 2021
Wesper Lab
K203343 · MNR
Wesper, Inc.
Anesthesiology · 403d
Cleared Dec 16, 2021
NightOwl
K213463 · MNR
Ectosense NV
Anesthesiology · 50d
Cleared Dec 10, 2021
Airvo Nebulizer Adapter
K211560 · CAF
Fisher & Paykel Healthcare Limited
Anesthesiology · 204d
Cleared Dec 03, 2021
Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%
K210126 · CAF
The Ritedose Corporation
Anesthesiology · 318d
Cleared Nov 26, 2021
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length...
K210833 · JOH
Smiths Medical Asd, Inc.
Anesthesiology · 252d
Cleared Nov 23, 2021
Breathe Easy Mobile Respiratory Monitor (MRM)
K211387 · BZQ
Sound Life Sciences, Inc.
Anesthesiology · 202d
Cleared Nov 10, 2021
LTV2 Series Ventilators
K201082 · CBK
Vyaire Medical, Inc.
Anesthesiology · 566d
Cleared Nov 04, 2021
CARESCAPE R860
K210384 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 268d
Cleared Oct 30, 2021
Tracheal Stent System (Y-Shaped)
K212403 · JCT
Micro-Tech (Nanjing) Co., Ltd.
Anesthesiology · 89d
Cleared Oct 21, 2021
Tenax Laser Resistant Endotracheal Tube
K213028 · BTR
Bryan Medical, Inc.
Anesthesiology · 30d
Cleared Oct 21, 2021
Belun Ring BLR-100X
K211407 · DQA
Belun Technology Company Limited
Anesthesiology · 168d
Cleared Oct 21, 2021
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV,...
K211171 · CCK
GE Healthcare Finland Oy
Anesthesiology · 185d
Cleared Sep 29, 2021
RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit...
K203668 · BSP
Myco Medical Supplies, Inc.
Anesthesiology · 287d
Cleared Sep 26, 2021
DiscCath Needle Set
K212328 · BSP
Disccath, LLC
Anesthesiology · 61d
Cleared Sep 22, 2021
Single Use Guide Sheath Kit-401, K-402
K212667 · EOQ
Olympus Medical Systems Corp.
Anesthesiology · 30d
Cleared Sep 17, 2021
Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP...
K203762 · CCK
Covidien
Anesthesiology · 268d
Cleared Sep 17, 2021
BreatheSuite MDI V1
K203155 · CAF
Breathesuite, Inc.
Anesthesiology · 330d