18 results
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33ms
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Sources: EU EUDAMED, US FDA
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Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 523611051 3 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611057 4 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 524611000 5 SPUR II Adult Resuscitator, Pop-off open 40 ,w/PEEP Valve 20, Adult, Catalog Number: 524611001 6 SPUR II Adult Resuscitator w/PEEP Valve 20, Adult, Catalog Number: 524611011 7 SPUR II Adult Resuscitator w/Pressure Limiting Valve, Adult, Catalog Number: 524611031 8 SPUR II Adult Resuscitator w/Pressure Limiting Valve, Adult, Catalog Number: 524611047 9 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 524611051 10 SPUR II Pediatric Resuscitator w/10 O2 tube & Manometer, Catalog Number: 530200016 11 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530212000 12 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530212001 13 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213000 14 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213001 15 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213011 16 SPUR II Pediatric Resuscitator w/Manometer, Pediatric, Catalog Number: 530213030 17 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213031 18 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213048 19 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530214000 20 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530613000 21 SPUR II Pediatric Resuscitator w/Manometer & PEEP Valve 20, Pediatric, Catalog Number: 530613031 22 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530613071 23 SPUR II Pediatric Resuscitator w/PEEP Valve 20,Manometer & CO2 Detector, Pediatric, Catalog Number: 530613831 24 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530614017 25 SPUR II Pediatric Resuscitator w/Manometer, Pediatric, Catalog Number: 530614030 26 SPUR II Pediatric Resuscitator w/CO2 Detector, Pediatric, Catalog Number: 530614800 27 SPUR II Pediatric Resuscitator, INF& TOD W/Manometer, Pediatric, Catalog Number: 530615030 28 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530619031 29 SPUR II Pediatric Resuscitator w/Expiratory Filter, Manometer PEEP Valve, Pediatric, Catalog Number: 531600051 30 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613000 31 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613001 32 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613010 33 SPUR¿ II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613031 34 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613047 35 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number:531613051 36 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531614026 37 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531638000 38 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611051E 39 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number:530213000B The Ambu SPUR II Resuscitator is a single patient use resuscitator intended for pulmonary resus
FDA Enforcement
Class I
·Ongoing·Ambu Inc.·August 20, 2025
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
FDA Enforcement
Class II
·Ongoing·Ambu Inc.·May 14, 2025
Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)
FDA Enforcement
Class II
·Ongoing·Ambu Inc.·November 6, 2024
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
FDA Enforcement
Class II
·Ongoing·Ambu Inc.·January 17, 2024
Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving and maintaining control of the airway during routine emergency anesthetic procedures.
FDA Enforcement
Class II
·Terminated·Ambu Inc.·March 30, 2016
Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
FDA Enforcement
Class II
·Ongoing·Ambu Inc.·July 27, 2022
Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portable endoscopy system. Catalog No: 405011000
FDA Enforcement
Class II
·Ongoing·Ambu Inc.·October 4, 2023
AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420
FDA Enforcement
Class II
·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024
KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD432
FDA Enforcement
Class II
·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024
KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4225
FDA Enforcement
Class II
·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024
KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD422
FDA Enforcement
Class II
·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024
KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD421
FDA Enforcement
Class II
·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024
KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD431
FDA Enforcement
Class II
·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024
KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KKLTSD4325
FDA Enforcement
Class II
·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024
KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD430
FDA Enforcement
Class II
·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024
UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF4116-6121Z, D466-61Z, DFP170-6121, DF3115-6121Z, DF375-6121Z, DF3115-6121Z, DF3115-6121Z, D360-8031Z, D465-61Z, JD365-6033Z, DF370-6121Z, DF3110-61Z, DF375-17621Z, DF375-6121Z, DF475-17621Z, DF370-6121Z, DF375-6121Z, DF470-6021Z, D366-618Z, D390-60Z, D390-61Z, DP260-61, DF370-6121Z, D3120-6154Z, F95100, JD365-6033Z, DF370-61Z, DF475-61Z, DF3110-6121Z, DF3110-6121Z, DF375-6121Z, DF475-6121Z, F90755, F90798, F95368, PDP260-61, D396R-61Z, F90578, F90622Z, F94980, D360-61Z, D365-6121Z, D366-6121Z, D366-6121Z, SJDF3116-6121Z, DF375-6121Z, DF470-6121Z, DF470-61Z, DF475-6121Z, DF375-6033Z, DF375-618Z, DF470-6127Z, DF475-61Z, DF476-6121Z, F90756, PDB160-6131, PDP160-6121, PDY160-6121, D060-8021, D366-8021Z, D466-6121Z, DF370-6121Z, DF470-6121Z, DF376-6121Z, PDP160-6031, D360-8021Z, D360-80Z, D445-80Z, D465-8021Z, JD365-6033Z, D460-6131Z, D460-6133Z, DF475-6121Z, DF3116S-608Z, F90777, D360-6133Z, D365-80Z, D360-6021Z, D360-6121Z, D360-61Z, DF3110-61Z, DF370-61Z, DF375-17621Z, DF475-6121Z, D365-6121Z, D060-80, PD060-6121, PD160-6121Z, PDP160-6121, DF3115-6121Z, F90767, DF375-17621Z, DF375-6121Z, DF470-6121Z, PD260-61Z, PDY140-6133, D360-16421Z, D360-6121Z, D366-6121Z, DFP2110-6121, DF470-6121Z, D465-8021Z, DF4115-6121Z, DF370-6121Z, DF376-6121Z, PDB140-61, D365-6121Z, DF070-61, PDY160-6121, D365-61Z, D360-6121Z, D360-61Z, D460-6121Z, DF0110-6121, DF3110-61Z, DF370-61Z, DF375-6121Z, DF375-6121Z, DF475-6121Z, DF475-6121Z, DF370-6021Z, DF370-6133Z, DF375-618Z, DF475-17621Z, DFB170-61, PD040-61, PDP160-6121, PDY160-6121, D390-61Z, F94474, D460-61Z, D366-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, DF0110-61, DF0110-61, DF3115-6121Z, DF3115-6121Z, DF070-6127, F90752, DF375-17621Z, DF375-61Z, DF376-17621Z, F95100, D360-6021Z, D366-6121Z, D465-8021Z, D360-61Z, DF3110-61Z, DF3110-61Z, DF3110-6121Z, PDP160-6031, D360-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, D460-61Z, D3120-6121Z, D360-8021Z, D365-80Z, D395-8021Z, D460-8021Z, D465-8021Z, D495-61Z, F90577Z, DF370-6133Z, DF375-6021Z, DF376-6121Z, DF475V-6121Z, DFP170-6121, DF370-61Z, DF470-6121Z, DF470-6121Z, DF470-6121Z, DF470-6121Z, DF470-61Z, DF3115-6121Z, F90767, DF370-6121Z, DF375-6121Z, DF476-6121Z, F95407, F90556, D365V-8021Z, F95383, D460-61Z, F90777, DF370-6121Z, DF370-6121Z, DF375-17621Z, DF475-6121Z, D440-80Z, D360-6021Z, D365-6121Z, DF370-61Z, DF4116-6121Z, DF476-6121Z, F90579, D345-6121Z, D396R-61Z, D460-80Z, D465-6031Z, D465-8021Z, DP2120-61, F90578, F94795, F94980, D360-61Z D365-6121Z, D365-6121Z, D366-6121Z, D366-6121Z, D460-6121Z, D460-6121Z, D460-61Z, D360-6021Z, D360-6121Z, D366-6121Z, D366-6121Z, D060-8021, D3120-6121Z, D360-16421Z, D360-8021Z, D360-8031Z, D366-80Z, D390-61Z, D460-80Z, D465-8021Z, D465V-8021Z, PDP160-6121, DF070-6121, DF370-6021Z, DF375-61Z, DF375-61Z, DF375-61Z, DF470-6021Z, DF475-61Z, DFY170-6121, DF375-17621Z, DF375-6121Z, DF375-6121Z, DF470-6121Z, DF475-6121Z, DF475-6121Z, SJDF3116-6121Z, DF3115-6121Z, DF3116-6121Z, DF4115-6121Z, DF4116-6121Z, DF475-6121Z, DF375-6121Z, DF375-6121Z, DF470-6121Z, DF0110-618, DF370-61Z, DF375-6121Z, DF475-6121Z, DF475-6121Z, DF375-6021Z, F90798, PDP140-6121, D365V-8021Z, D366-8021Z, D445-80Z, D460-8021Z, D460-8021Z, D465-61Z, D365-61Z, DF3116S-608Z, DF370-6121Z, DF375-17621Z, DF375-6121Z, DF470-6127Z, DF475V-6121Z, DF476-6121Z, F95368, F95407, PD060-61, PDB160-6131, PDP160-6121, D460-6131Z, D360-6121Z, D360-61Z, DF370-6121Z, DF375-17621Z, DF475-6121Z, DF376-17621Z, D3120-6121Z, D466-6121Z, DF4110-6121Z, DF370-6121Z, DF376-6121Z, DF475V-6121Z, D440-80Z, DF376R-61Z, DF0110-6121, DF370-6121Z, DF470-6121Z, DF375-17621Z, DF370-6021Z, DF475-61Z, DFP170-6121, DFY270-6121, PDP264C-61, D360-8021Z, D365-8021Z, D365-80Z, D365-80Z, F90578, D360-6121Z, D360-6121Z, D360-61Z, D460-6121Z, DF3115-6121Z, DF3115-6121Z, DF4115-61Z, DFP2110-61, DF375-6121Z, DF470-6121Z, DF475-6121Z, DF476-6121Z, DF470-6121Z, DF475V-6
FDA Enforcement
Class II
·Terminated·King Systems Corp. dba Ambu, Inc.·January 17, 2018
King LTS-D Kit Size 1, Model Number KLTSD431
FDA Enforcement
Class II
·Terminated·King Systems Corp. dba Ambu, Inc.·June 5, 2019
King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visualize a patients upper airway and aid in the placement of a tracheal tube. Model Number: KVLVA12
FDA Enforcement
Class I
·Terminated·King Systems Corp. dba Ambu, Inc.·February 12, 2020