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Ambu A/S

354 adverse events · 32 clearances · 9 inspections · aggregated across 4 source records

Scorecard
Events per device across the 1,173-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.

MAUDE reports per device

0.061

71 in the last 12 months

Higher volume than 92% of companies with 10+ devices

Recalls per device

0

0 in the last 12 months

Higher volume than 97% of companies with 10+ devices

These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.

Devices
1,173 device records · ordered by linked event volume.
BrandModelProduct codesPrimary DILinked events
aScope™ 4 Broncho Slim 3.8/1.2476001000EOQ0570748013547959
aScope™ 4 Broncho Large 5.8/2.8478001000EOQ0570748013553051
Ambu aView™ 2 Advance405011000FEM0570748014508943
aScope™ 4 Broncho Regular 5.0/2.2477001000EOQ0570748013550935
Ambu® SPUR® II Pediatric Resuscitator531600051OEV0570748016344131
VivaSight™ 2 DLT Kit 37 Fr - LEFT412371000CBI0570748014573730
aScope™ 5 Broncho 2.7/1.2624001000USEOQ0570748015728027
aScope™ 5 Broncho HD 5.6/2.8 Sampler Set622002000USEOQ0570748015654225
VivaSight™ 2 DLT Kit 39 Fr - LEFT412391000CBI0570748014576822
Ambu® SPUR® II Adult Resuscitator520611000OEV0570748015177621
aScope™ Duodeno482001000FDT0570748014528719
aScope™ 4 Broncho Large Sampler Set 5.8/2.8478501000EOQ0570748014601716
Isiris™ aALFA01FAJ0570748013606312
aScope™ 4 RhinoLaryngo Slim510101000EOB057074801577309
Ambu® SPUR® II Adult Resuscitator521611000OEV057074801520328
Disposable Face Mask000252956BYG057074800233638
aScope™ 3 Regular 5.0/2.2Flexible Videoscope - Single Use403001000EOQ057074801219918
Ambu® SPUR® II Adult Resuscitator523611051OEV057074801495137
AuraGain408400000CAE057074801295777
Ambu® SPUR® II Adult Resuscitator520211000OEV057074801515546
BlueSensor NECG ElectrodesN-00-S/25DRX057074800221066
BlueSensor VLECG ElectrodesVL-00-S/25DRX057074800222506
Neuroline ConcentricNeurology Needle Electrodes74025-30/25IKT057074800236536
VivaSight™ 2 DLT Kit 35 Fr - LEFT412351000CBI057074801457066
VivaSight™ 2 DLT Kit 41 Fr - LEFT412411000CBI057074801457996
aScope™ 4 Broncho Large 5.8/2.8478101000EOQ057074801578536
aScope™ 4 Broncho Slim 3.8/1.2476101000EOQ057074801577926
aScope™ 4 Cysto601101000FAJ057074801577096
aScope™ 4 Cysto600101000FAJ057074801576796
aScope™ 5 Broncho HD 5.0/2.2 Sampler Set621002000USEOQ057074801565116
Showing 1–30 of 1,173Next →
Facilities
Registered establishments with their latest FDA inspection outcome.
FEINameLocationLast inspectionWatch
3016497307AMBU INNOVATION GMBHAugsburg Bavaria, DE
3003924186AMBU LimitedXIANG YU F.T.Z., XIAMEN Fujian, CNVAI
3004040397AMBU SDN.BHD.PENANG Pulau Pinang, MYVAI
3002806359Ambu A/SBallerup Hovedstaden, DKNAI
3022631687Ambu Mexico Operations S.A. DE C.V.Ciudad Juarez Chihuahua, MX