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
1993–2016 of 9,002
Search insights Median review: 93d Cleared: 100% Top manufacturer: Respironics, Inc. Lead specialty: Anesthesiology
Cleared Apr 24, 2009
PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND...
K083351 · DQA
Comdek Industrial Corp.
Anesthesiology · 162d
Cleared Apr 22, 2009
APEX MEDICAL XT AUTO CPAP 9S-005200
K083656 · BZD
Apex Medical Corp.
Anesthesiology · 133d
Cleared Apr 15, 2009
BCI WW1000 PULSE OXIMETER, MODEL WW1000
K083787 · DQA
Smiths Medical Pm, Inc.
Anesthesiology · 117d
Cleared Apr 13, 2009
SWIFT FX
K090244 · BZD
Resmed, Ltd.
Anesthesiology · 70d
Cleared Apr 09, 2009
BCI WW1020 PULSE OXIMETER, MODEL WW1020
K083705 · DQA
Smiths Medical Pm, Inc.
Anesthesiology · 115d
Cleared Apr 09, 2009
AEROCHAMBER MINI VENTILATION CHAMBER
K090065 · CAF
Trudell Medical Intl.
Anesthesiology · 90d
Cleared Apr 07, 2009
PORTABLE OXYGEN UNIT SCA900
K080243 · CAN
San Cheong Co. , Ltd.
Anesthesiology · 432d
Cleared Apr 03, 2009
APK SPO2 PULSE OXIMETER SENSOR
K082846 · DQA
APK Technology Co., Ltd.
Anesthesiology · 186d
Cleared Apr 03, 2009
MD2000A VITAL SIGN MONITOR, MODEL MD2000A
K083466 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 130d
Cleared Apr 03, 2009
TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES
K090352 · BTR
Covidien
Anesthesiology · 51d
Cleared Apr 02, 2009
LNCS OXIMETRY SENSORS
K083622 · DQA
Masimo Corporation
Anesthesiology · 115d
Cleared Apr 02, 2009
PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840
K083693 · CBK
Covidien, Formerly Nellcor Puritan...
Anesthesiology · 111d
Cleared Apr 01, 2009
NAVIGATOR APPLICATIONS SUITE
K083098 · BSZ
GE Healthcare Finland Oy
Anesthesiology · 166d
Cleared Mar 31, 2009
SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM
K090722 · BTY
Shape Medical Systems, Inc.
Anesthesiology · 12d
Cleared Mar 25, 2009
EVERON
K082465 · BZQ
Earlysense, Ltd.
Anesthesiology · 210d
Cleared Mar 25, 2009
COMFORTLITE NASAL MASK
K082558 · BZD
Respironics, Inc.
Anesthesiology · 202d
Cleared Mar 23, 2009
CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR
K082853 · MNR
Inspired Technologies, Inc.
Anesthesiology · 175d
Cleared Mar 20, 2009
RES TRAXX ONLINE, MODEL: R14
K083816 · BZD
Resmed, Ltd.
Anesthesiology · 88d
Cleared Mar 19, 2009
APNEALINK PLUS, MODEL: 22328
K083575 · MNR
Resmed Germany, Inc.
Anesthesiology · 106d
Cleared Mar 19, 2009
FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030)
K083892 · DQA
Cas Medical Systems, Inc.
Anesthesiology · 80d
Cleared Mar 18, 2009
PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR
K083688 · CBK
Pulmonetic Systems, Inc.
Anesthesiology · 96d
Cleared Mar 18, 2009
SPINAL INJECTION SYSTEM
K083909 · BSP
Laurimed, LLC
Anesthesiology · 78d
Cleared Mar 16, 2009
IVENT101
K081845 · CBK
Versamed Medical Systems, Inc.
Anesthesiology · 259d
Cleared Mar 16, 2009
ZEST NASAL MASK
K083832 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 83d