FDA.report

Ambu A/S

Matched from indexed company URL: Ambu A

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
96106913002806359Ambu A/S1N2026-01-01Baltorpbakken 13 Ballerup Hovedstaden DK DK-2750

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
05707480006397Perfit Collar™ - Collar Perfit Infant size 1+1(410)768-6464Purchase_orders@ambuUSA.com
05707480006403Perfit Collar™ - Collar Perfit Pediatric size 2+1(410)768-6464Purchase_orders@ambuUSA.com
05707480006410Perfit Collar™ - Collar Perfit Neckless, size 3+1(410)768-6464Purchase_orders@ambuUSA.com
05707480006427Perfit Collar™ - Collar Perfit short size 4+1(410)768-6464Purchase_orders@ambuUSA.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
803591497021989K993278AMBU NEONATE SILICONE RESUSCITATORBTM2000-05-17
803591760557343K981891AMBU TUBECHECKBTR1998-07-17
803591994180189K970639NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-KGXY1997-05-15
803591093259554K941759SNORING SENSORBZQ1994-11-10
803591339898299K941568K-10-VS, DA-05-VS, RECORDING ELECTRODESGXY1994-11-04
803591273283134K935518MOVING IMAGES(TM)BZQ1994-05-17
803591566949432K931430CUTANEOUS ELECTRODEGXY1993-12-21
803591586984588K931426NF-11-E DISPOSABLE REFERENCE/RECORDING ELECTRODEGXY1993-12-21
803591906895138K923976AMBU SINGLE PATIENT USE PEEP VALVEBYE1993-01-05
803591000969724K923033THE TRACKERLXJ1993-06-01
803591303789577K922112EASYFLOWBZQ1992-12-07
803591037836720K903300RESP-EZ(TM) RESPIRATORY MONITORING BELTBZQ1990-12-28
803591713127728K900260AMBU LIFE KEY AND AMBU RES-CUE KEYBTM1990-06-08
803591562702340K840349MARK III RESUSCITATORBTM1984-02-10
803591776815027K782152VALVE, AMBU PEEPBYE1978-12-26
803591043473386K250269Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)FAJ2025-06-11
803591310543171K242108Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aView™ 2 AdvanceFGB2024-08-16
803591733118175K240849Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2FAJ2024-10-16
803591027496751K240848Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aView™ 2 AdvanceFAJ2024-10-10
803591587064143K233886Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2FDT2024-04-16
803591441443585K233671Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 AdvanceEOQ2024-01-04
803591946659918K233630Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2FGB2024-06-24
803591567901102K232919Ambu® aScope™ Gastro Large; Ambu® aBox™ 2FDS2024-04-05
803591692490875K232582Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetEOQ2023-09-20
803591663560620K230428Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2EOQ2023-08-10
803591255922960K223782Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler SetEOQ2023-01-12
803591525750331K223299Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 AdvanceEOQ2023-06-01
803591647882620K220606Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2EOQ2022-07-25
803591478881445K212382Ambu® aScope™ Gastro, Ambu® aBox™2FDS2022-02-03
803591702612192K210883aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8EOQ2021-06-17
803591870164513K203749Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter CableCBI2021-05-03
803591853052146K193095Ambu aScope 4 CystoFAJ2020-04-02
803591991696696K191080Ambu aScope 4 RhinoLaryngo SlimEOB2019-05-22
803591984095605K190972Ambu aScope 4 RhinoLaryngo InterventionEOB2019-07-12
803591589186831K173727Ambu 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 MonitorEOQ2018-03-28
803591915132000K160766Ambu USR, Ambu MFAJ2016-08-17
803591899484576K152931Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant ResuscitatorBTM2016-08-29
803591104763490K102824AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRICBTM2011-01-28
803591704191490K093825AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODEIKT2010-01-13
803591790687235K071186MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODEIKT2007-07-30
803591867232121K071185MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODEGXZ2007-05-30
803591945849410K053142AMBU MARK IV BABY RESUSCITATORBTM2005-12-20
803591715242768K053140AMBU MARK IV RESUSCITATORBTM2005-12-23
803591470789677K051529AMBU NEUROLINE GROUNDGXY2005-08-04
803591854205592K040991AMBU DISPOSABLE PRESSURE MANOMETERCAP2004-07-22
803591042438390K032278AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODEGXY2004-03-05
803591116529773K020907NEUROLINE, SUBDERMAL NEEDLE ELECTRODESIKT2002-06-14
803591499052840
803591531894230
803591968203157
803591003297861
803591029881618
803591080107972
803591096961954
803591115071131
803591412694357
803591486714884
803591605586468
803591615685059
803591688886086
803591712991993
803591717185553
803591797921953

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
EOQ82024-01-04
BTM72016-08-29
GXY62005-08-04
FAJ52025-06-11
BZQ41994-11-10
IKT32010-01-13
FGB22024-08-16
FDS22024-04-05
EOB22019-07-12
BYE21993-01-05
FDT12024-04-16
CBI12021-05-03
GXZ12007-05-30
CAP12004-07-22
BTR11998-07-17
LXJ11993-06-01

PMN

GUDID

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