Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

41 results for "Ambu A/S"
1–24 of 41
Search insights Median review: 144d Cleared: 100% Top manufacturer: Ambu A/S Lead specialty: Ear, Nose, Throat
Cleared Sep 16, 2026
Ambu® aScope™ Gastro
K261400 · FDS
Ambu A/S
Gastroenterology & Urology · 140d
Cleared Sep 16, 2026
Ambu® aScope™ 5 Broncho 2.7/1.2
K260309 · EOQ
Ambu A/S
Ear, Nose, Throat · 229d
Cleared Jul 14, 2026
Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US,...
K260578 · GXY
Ambu A/S
Neurology · 144d
Cleared Apr 30, 2026
Ambu® Virobac II® Exhalation Filter
K251583 · CAH
Ambu A/S
General Hospital · 342d
Cleared Jun 11, 2025
Ambu® aScope™ 5 Cysto HD (Standard Deflection)
K250269 · FAJ
Ambu A/S
Gastroenterology & Urology · 132d
Cleared Oct 16, 2024
Ambu® aScope™ 5 Cysto HD (Standard Deflection)
K240849 · FAJ
Ambu A/S
Gastroenterology & Urology · 203d
Cleared Oct 10, 2024
Ambu® aScope™ 5 Cysto HD (Standard Deflection)
K240848 · FAJ
Ambu A/S
Gastroenterology & Urology · 197d
Cleared Aug 16, 2024
Ambu® aScope™ 5 Uretero (Standard Deflection)
K242108 · FGB
Ambu A/S
Gastroenterology & Urology · 29d
Cleared Jun 24, 2024
Ambu® aScope™ 5 Uretero (Standard Deflection)
K233630 · FGB
Ambu A/S
Gastroenterology & Urology · 224d
Cleared Apr 16, 2024
Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2
K233886 · FDT
Ambu A/S
Gastroenterology & Urology · 130d
Cleared Apr 05, 2024
Ambu® aScope™ Gastro Large
K232919 · FDS
Ambu A/S
Gastroenterology & Urology · 199d
Cleared Jan 04, 2024
Ambu® aScope™ 5 Broncho 4.2/2.2
K233671 · EOQ
Ambu A/S
Ear, Nose, Throat · 50d
Cleared Sep 20, 2023
Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
K232582 · EOQ
Ambu A/S
Ear, Nose, Throat · 26d
Cleared Sep 15, 2023
Ambu® aScope™ Colon
K230332 · FDF
Ambu A/S
Gastroenterology & Urology · 220d
Cleared Aug 10, 2023
Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2
K230428 · EOQ
Ambu A/S
Ear, Nose, Throat · 174d
Cleared Jun 01, 2023
Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu®...
K223299 · EOQ
Ambu A/S
Ear, Nose, Throat · 217d
Cleared Jan 12, 2023
Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD...
K223782 · EOQ
Ambu A/S
Ear, Nose, Throat · 27d
Cleared Jul 25, 2022
Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2
K220606 · EOQ
Ambu A/S
Ear, Nose, Throat · 145d
Cleared Feb 03, 2022
Ambu® aScope™ Gastro, Ambu® aBox™2
K212382 · FDS
Ambu A/S
Gastroenterology & Urology · 185d
Cleared Jun 17, 2021
aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler...
K210883 · EOQ
Ambu A/S
Ear, Nose, Throat · 84d
Cleared May 03, 2021
Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable
K203749 · CBI
Ambu A/S
Anesthesiology · 131d
Cleared Apr 02, 2020
Ambu aScope 4 Cysto
K193095 · FAJ
Ambu A/S
Gastroenterology & Urology · 147d
Cleared Jul 12, 2019
Ambu aScope 4 RhinoLaryngo Intervention
K190972 · EOB
Ambu A/S
Ear, Nose, Throat · 88d
Cleared May 22, 2019
Ambu aScope 4 RhinoLaryngo Slim
K191080 · EOB
Ambu A/S
Ear, Nose, Throat · 28d