FDA.reportPublic FDA data

AMBU INC.

Matched from indexed company URL: AMBU, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12208281121788AMBU INC.1Y2026-01-016721 Columbia Gateway Drive, Suite 200 Columbia MD US 21046
24308632430863AMBULATORY MONITORING, INC.1N2026-01-01731 SAW MILL RIVER RD. ARDSLEY NY US 10502
80220253002540311AMBUTECH INC.1N2026-01-0134 DE BAETS ST. WINNIPEG Manitoba CA R2J 3S9
96106913002806359Ambu A/S1N2026-01-01Baltorpbakken 13 Ballerup Hovedstaden DK DK-2750
30075452383007545238AMBULANC (SHENZHEN) TECH. CO.,LTD.1N2020-04-253rd Floor,Block C,Building #5 Skyworth Innovation Industry Park Tang Tou 1st Road, Shiyan, Baoan District shenzhen Guangdong CN 518108

GUDID Contact Samples#

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

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05707480024438Head Wedge™ - Cervical Immobilization Device+1(410)768-6464Purchase_orders@ambuUSA.com
05707480024476Head Wedge™ - Cervical Immobilization Device+1(410)768-6464Purchase_orders@ambuUSA.com
05707480024490Military Head Wedge™ - Cervical Immobilization Device+1(410)768-6464Purchase_orders@ambuUSA.com
05707480107216SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator - NEO & INF FM, DISP MANO, 10" OX SUPPLY TUBING, 43 MM BERMAN+1(410)768-6464Purchase_orders@ambuUSA.com
05707480107254SPUR® II Infant Resuscitatorw/Inspiratory Filter - INFANT FACE MASK, INSPIRATORY FILTER+1(410)768-6464Purchase_orders@ambuUSA.com
05707480109746SPUR® II Adult ResuscitatorWith Attached Inspiratory Filter - SPUR II Ad Bag Resv, Med Ad FM(not att) Attached Insp Filter+1(410)768-6464Purchase_orders@ambuUSA.com
05707480109838SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator - SPUR II Adult, Bag Res, Md & Lg Ad FM+1(410)768-6464Purchase_orders@ambuUSA.com
05707480131921SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator - Ambu SPUR II Adult Bag Res.w/ Guedel Airway #8-9+1(410)768-6464Purchase_orders@ambuUSA.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
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
370881862808051K854030WRIST ACTIGRAPHGWQ1986-06-25
803591562702340K840349MARK III RESUSCITATORBTM1984-02-10
803591776815027K782152VALVE, AMBU PEEPBYE1978-12-26
370881009723038K772016RESPITRACEBZK1978-01-26
370881053893629K251574Sleep WatchLEL2025-07-31
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
1644071197967806
1644071227240885
1644071246781159
1644071410688372
1644071473641083
803591499052840
803591531894230
1644071587260214
1644071845750599
1644071900628848
1644071917430234
803591968203157
803591003297861
803591029881618
803591080107972
803591096961954
803591115071131
803591412694357
803591486714884
100491537468807
803591605586468
803591615685059
803591688886086
803591712991993
803591717185553
100491742067215
803591797921953
100491948173292

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
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
LEL12025-07-31
FDT12024-04-16
CBI12021-05-03
GXZ12007-05-30
CAP12004-07-22
BTR11998-07-17
LXJ11993-06-01
GWQ11986-06-25
BZK11978-01-26

PMN#

72 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next