Skip to content
Pharma Observatory a Scientist.com platform

Organization (Industry)

AMBU A/S

ClinicalTrials.gov lists AMBU A/S as lead sponsor of 11 trials.

DK Industry Manufacturer
Email me this page as a PDF

Search trials, drugs, companies and investigators, and follow each one to the others. Individual plan, $249/seat/mo. Card required.

5 0 2005 2026

Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.

2026 is partial: 0 registered with a 2026 start date. The dashed outline is the pace from the 0 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 0.6 trial starts a year over the five years to September, under the 5 a year the method needs.

Logo Unknown author Unknown author, via Wikimedia Commons, Public domain. Shown to identify the organization; it may be a registered trademark.

This page covers AMBU A/S: 11 lead-sponsored trials and 2 legal-entity registrations.

Get the AMBU A/S report as a PDF

The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

Disease areas (11)

Shown in this order: most trials first.

Disease areas
Disease area Trials
Colorectal Neoplasms 1
Cross Infection 1
Hemoptysis 1
Hemorrhage 1
Laryngeal Diseases 1

Trials by start year as sponsor or collaborator (12)

Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.

Show the table of trials by start year as sponsor or collaborator
Trials by start year as sponsor or collaborator
Year Trials started
2023 1
2022 2
2021 3
2020 5
2019 2
2018 2
2017 4
2016 1
2015 1
2013 1

Recruitment duration, a model prediction: 1 trial still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

Sponsor delivery record (1)

Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.

Sponsor delivery record
Enrollment Timeline
40% hit target (n=5) 20% on time (n=5)

Journals published in (43)

Shown in this order: most published in first.

Journals published in
Journal Publications
Anaesthesia 8
Anesthesia and analgesia 7
Canadian journal of anaesthesia = Journal canadien d'anesthesie 5
Gastrointestinal endoscopy 5
British journal of anaesthesia 3

US granted patents (1)

Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.

US granted patents
US patents granted Granted in the last 5 years Most recent grant
169 106 2025-12-23

FDA inspection record (1)

FDA inspection record
Latest classification Inspections
NAI 2

FDA recalls (7)

Shown in this order: most recent first.

FDA recalls
Product Classification Initiated
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 Class I 2025-07-09
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US Class II 2025-04-07
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) Class II 2024-09-16
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2 Class II 2023-12-05
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 Class II 2023-07-21

FDA import refusals (1)

FDA import refusals
Refused import lines Latest refusal
2 2024-04-15

Manufacturing and distribution sites (2)

Shown in this order: severity rank then name.

Manufacturing and distribution sites
Facility Location Regulators Member organization
Ambu A/S Ballerup Hovedstaden, DK FDA
AMBU Limited XIANG YU F.T.Z., XIAMEN Fujian, CN FDA AMBU Limited

Latest dated events (207)

Shown in this order: newest first.

Latest dated events
Date Event Source
2025-12-23 Patent granted Granted US patents (PatentsView / USPTO)
2025-12-23 Patent granted Granted US patents (PatentsView / USPTO)
2025-12-09 Patent granted Granted US patents (PatentsView / USPTO)
2025-12-02 Patent granted Granted US patents (PatentsView / USPTO)
2025-11-18 Patent granted Granted US patents (PatentsView / USPTO)

Biomarker capability evidence (2)

Shown in this order: tier desc, then gene symbol.

Biomarker capability evidence
Gene Role Evidence
ACAT1 Trial collaborator Named in trial inclusion criteria
ACAT1 Trial collaborator Mentioned in trial text

Not on this page

Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, active development programs, approved assets, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, climate targets, as filed, workforce and board diversity, as filed, organization relationships, clia clinical laboratory certificates, and biomarkers this organization publishes on.