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
1993–2016 of 8,982
Search insights Median review: 92d Cleared: 100% Top manufacturer: Respironics, Inc. Lead specialty: Anesthesiology
Cleared Mar 18, 2009
SPINAL INJECTION SYSTEM
K083909 · BSP
Laurimed, LLC
Anesthesiology · 78d
Cleared Mar 18, 2009
PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR
K083688 · CBK
Pulmonetic Systems, Inc.
Anesthesiology · 96d
Cleared Mar 16, 2009
ZEST NASAL MASK
K083832 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 83d
Cleared Mar 16, 2009
IVENT101
K081845 · CBK
Versamed Medical Systems, Inc.
Anesthesiology · 259d
Cleared Mar 13, 2009
TRILOGY 100 VENTILATOR
K083526 · CBK
Respironics Inc., Sleep & Home...
Anesthesiology · 105d
Cleared Mar 13, 2009
OXYGEN DEMAND VALVE
K082345 · CBP
Bpr Medical, Ltd.
Anesthesiology · 210d
Cleared Mar 10, 2009
DYNAMIPEAK PEAK FLOW METER
K082899 · BZH
Dynamitech Medical, Inc.
Anesthesiology · 161d
Cleared Mar 09, 2009
N-600X WITH SPD, OXIMAX N-600X
K083325 · DQA
Covidien
Anesthesiology · 117d
Cleared Mar 09, 2009
WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62
K082478 · BZG
Welch Allyn, Inc.
Anesthesiology · 193d
Cleared Mar 06, 2009
SOMNOLYZER 24X7
K083620 · MNR
The Siesta Group North America
Anesthesiology · 88d
Cleared Mar 06, 2009
CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)
K081330 · BTL
O-Two Medical Technologies, Inc.
Anesthesiology · 298d
Cleared Mar 05, 2009
GE DATEX-OHMEDA AISYS
K090233 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 34d
Cleared Mar 05, 2009
TRACH-ASSIST
K083702 · BZA
Mergenet Medical
Anesthesiology · 80d
Cleared Mar 05, 2009
QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100
K083079 · DQA
Quanta Computer, Inc.
Anesthesiology · 140d
Cleared Mar 05, 2009
MERCURY MEDICAL PEEP VALVE
K081266 · BYE
Mercury Enterprizes Dba Mercury Medical
Anesthesiology · 304d
Cleared Mar 04, 2009
BIPAP AUTOSV
K090248 · MNS
Respironics Inc., Sleep & Home...
Anesthesiology · 30d
Cleared Mar 04, 2009
PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS
K083451 · BSN
Smiths Medical Asd, Inc.
Anesthesiology · 103d
Cleared Mar 04, 2009
HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041
K083122 · CBK
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 133d
Cleared Mar 04, 2009
M-50 SERIES SPO2 SENSOR
K082487 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 188d
Cleared Mar 02, 2009
NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P
K083456 · CCK
Nihon Kohden America, Inc.
Anesthesiology · 101d
Cleared Mar 02, 2009
THE PFT FILTER
K083233 · BZG
Pulmonary Filtration Technologies, LLC
Anesthesiology · 119d
Cleared Feb 23, 2009
INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING...
K083879 · BZG
Innovision A/S
Anesthesiology · 56d
Cleared Feb 23, 2009
BIVONA TRACHEOSTOMY TUBES
K083641 · JOH
Smiths Medical Asd, Inc.
Anesthesiology · 76d
Cleared Feb 23, 2009