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Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

41 results for "Ambu A/S"
25–41 of 41
Search insights Median review: 144d Cleared: 100% Top manufacturer: Ambu A/S Lead specialty: Ear, Nose, Throat
Cleared Nov 30, 2018
Ambu aScope RLS Slim
K181286 · EOB
Ambu A/S
Ear, Nose, Throat · 198d
Cleared Mar 28, 2018
Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2
K173727 · EOQ
Ambu A/S
Ear, Nose, Throat · 113d
Cleared Sep 01, 2016
Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3...
K161656 · EOQ
Ambu A/S
Ear, Nose, Throat · 77d
Cleared Aug 29, 2016
Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu...
K152931 · BTM
Ambu A/S
Anesthesiology · 329d
Cleared Aug 17, 2016
Ambu USR, Ambu M
K160766 · FAJ
Ambu A/S
Gastroenterology & Urology · 149d
Cleared Nov 01, 2013
AMBU ASCOPE 3 5.0/2.2
K130845 · EOQ
Ambu A/S
Ear, Nose, Throat · 220d
Cleared Nov 18, 2011
AMBU ASCOPE 2
K110962 · BTR
Ambu A/S
Anesthesiology · 226d
Cleared Jan 28, 2011
AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC
K102824 · BTM
Ambu A/S
Anesthesiology · 121d
Cleared Jun 11, 2010
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
K100129 · DRX
Ambu A/S
Cardiovascular · 143d
Cleared Apr 16, 2010
AMBU ASCOPE AND MONITOR
K093186 · BTR
Ambu A/S
Anesthesiology · 189d
Cleared Jan 13, 2010
AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE
K093825 · IKT
Ambu A/S
Neurology · 30d
Cleared Jul 30, 2007
MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE
K071186 · IKT
Ambu A/S
Neurology · 91d
Cleared May 30, 2007
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
K071185 · GXZ
Ambu A/S
Neurology · 30d
Cleared Oct 25, 2006
AMBU BLUE SENSOR NEO AND NEO X
K053550 · DRX
Ambu A/S
Cardiovascular · 309d
Cleared Oct 25, 2006
AMBU WHITE SENSOR CFM, CFL
K052944 · DRX
Ambu A/S
Cardiovascular · 370d
Cleared Dec 23, 2005
AMBU MARK IV RESUSCITATOR
K053140 · BTM
Ambu A/S
Anesthesiology · 44d
Cleared Dec 20, 2005
AMBU MARK IV BABY RESUSCITATOR
K053142 · BTM
Ambu A/S
Anesthesiology · 41d