FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Anesthesiology ×
8,982 results
601–624 of 8,982
Search insights Median review: 92d Cleared: 100% Top manufacturer: Respironics, Inc. Lead specialty: Anesthesiology
Cleared Jul 27, 2020
Vitalograph Model 2120 In2itive eDiary
K200550 · BZG
Vitalograph (Ireland) , Ltd.
Anesthesiology · 146d
Cleared Jul 24, 2020
Aer X
K200496 · CAW
3B Medical, Inc.
Anesthesiology · 147d
Cleared Jul 22, 2020
Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor
K201699 · NLF
Surgical Instrument and Savings Inc...
Anesthesiology · 30d
Cleared Jul 22, 2020
Rubicon SA System
K200654 · MNR
Dymedix Diagnostics, Inc.
Anesthesiology · 132d
Cleared Jul 22, 2020
Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT...
K192511 · BTO
Venner Medical (Singapore) Pte, Ltd.
Anesthesiology · 314d
Cleared Jul 20, 2020
GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable
K201179 · DQA
Covidien, LLC
Anesthesiology · 80d
Cleared Jul 20, 2020
Owgels Oxygen Concentrator
K191875 · CAW
Guangzhou Life Light Electronic...
Anesthesiology · 374d
Cleared Jul 17, 2020
AeroEclipse* ONE BAN
K200063 · CAF
Trudell Medical International
Anesthesiology · 186d
Cleared Jul 10, 2020
DreamStation 2 System, DreamStation 2 Advanced System
K200480 · BZD
Respironics, Inc.
Anesthesiology · 134d
Cleared Jul 03, 2020
Oxxiom
K200537 · DQA
True Wearables, Inc.
Anesthesiology · 122d
Cleared Jun 29, 2020
Somnera System
K200698 · QBY
Fresca Medical, Inc.
Anesthesiology · 104d
Cleared Jun 29, 2020
H500 Multi-Sensing Oximetry System
K192900 · DQA
Nonin Medical, Inc.
Anesthesiology · 258d
Cleared Jun 24, 2020
The C100 Contactless Breathing Monitor
K200445 · BZQ
Circadia Technologies, Ltd.
Anesthesiology · 121d
Cleared Jun 22, 2020
Patient Monitoring Cable (SpO2 Extension Cable)
K192404 · DSA
Shenzhen Coreray Technology, Ltd.
Anesthesiology · 293d
Cleared Jun 19, 2020
The NOxBOXi Nitric Oxide Delivery System
K201339 · MRN
Praxair, Inc.
Anesthesiology · 30d
Cleared Jun 18, 2020
Servo-air 4.0 Ventilator System
K192604 · CBK
Maquet Critica Care AB
Anesthesiology · 272d
Cleared Jun 17, 2020
INOmax DSIR Plus
K200389 · MRN
Mallinckrodt Manufacturing, LLC
Anesthesiology · 120d
Cleared Jun 02, 2020
F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora...
K200089 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 139d
Cleared Jun 01, 2020
Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff
K193077 · JOH
Covidien
Anesthesiology · 209d
Cleared May 27, 2020
Stimuplex Onvision System
K192914 · BSP
Philips Medical Systems Nederland B.V.
Anesthesiology · 225d
Cleared May 26, 2020
Maximus System
K200988 · NHJ
Hill-Rom Services Pte, Ltd.
Anesthesiology · 41d
Cleared May 26, 2020
The iNAP One Sleep Therapy System
K193460 · OZR
Somnice, Inc.
Anesthesiology · 162d
Cleared May 22, 2020
CO2 Sidestream Module
K192488 · CCK
Beijing Kingst Commercial & Trade...
Anesthesiology · 254d
Cleared May 21, 2020
CO2 Mainstream Module
K192446 · CCK
Beijing Kingst Commercial & Trade...
Anesthesiology · 258d