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Ambu A/S

39 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US) (K260578)Ambu A/S2026-07-14
Ambu® Virobac II® Exhalation Filter (K251583)Ambu A/S2026-04-30
Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection) (K250269)Ambu A/S2025-06-11
Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2 (K240849)Ambu A/S2024-10-16
Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aView™ 2 Advance (K240848)Ambu A/S2024-10-10
Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aView™ 2 Advance (K242108)Ambu A/S2024-08-16
Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2 (K233630)Ambu A/S2024-06-24
Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2 (K233886)Ambu A/S2024-04-16
Ambu® aScope™ Gastro Large; Ambu® aBox™ 2 (K232919)Ambu A/S2024-04-05
Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 Advance (K233671)Ambu A/S2024-01-04
Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set (K232582)Ambu A/S2023-09-20
Ambu® aScope™ Colon; Ambu® aBox™ 2 (K230332)Ambu A/S2023-09-15
Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2 (K230428)Ambu A/S2023-08-10
Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance (K223299)Ambu A/S2023-06-01
Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set (K223782)Ambu A/S2023-01-12
Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2 (K220606)Ambu A/S2022-07-25
Ambu® aScope™ Gastro, Ambu® aBox™2 (K212382)Ambu A/S2022-02-03
aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8 (K210883)Ambu A/S2021-06-17
Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable (K203749)Ambu A/S2021-05-03
Ambu aScope 4 Cysto (K193095)Ambu A/S2020-04-02
Ambu aScope 4 RhinoLaryngo Intervention (K190972)Ambu A/S2019-07-12
Ambu aScope 4 RhinoLaryngo Slim (K191080)Ambu A/S2019-05-22
Ambu aScope RLS Slim (K181286)Ambu A/S2018-11-30
Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor (K173727)Ambu A/S2018-03-28
Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor (K161656)Ambu A/S2016-09-01
Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator (K152931)Ambu A/S2016-08-29
Ambu USR, Ambu M (K160766)Ambu A/S2016-08-17
AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW (K130845)Ambu A/S2013-11-01
AMBU ASCOPE 2 (K110962)Ambu A/S2011-11-18
AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC (K102824)Ambu A/S2011-01-28
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X (K100129)Ambu A/S2010-06-11
AMBU ASCOPE AND MONITOR (K093186)Ambu A/S2010-04-16
AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE (K093825)Ambu A/S2010-01-13
MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE (K071186)Ambu A/S2007-07-30
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE (K071185)Ambu A/S2007-05-30
AMBU WHITE SENSOR CFM, CFL (K052944)Ambu A/S2006-10-25
AMBU BLUE SENSOR NEO AND NEO X (K053550)Ambu A/S2006-10-25
AMBU MARK IV RESUSCITATOR (K053140)Ambu A/S2005-12-23
AMBU MARK IV BABY RESUSCITATOR (K053142)Ambu A/S2005-12-20

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