10 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
FDA Enforcement
Class II
·Ongoing·Intersurgical Inc·August 13, 2025
One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
FDA Enforcement
Class II
·Ongoing·Intersurgical Inc·August 13, 2025
Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000
FDA Enforcement
Class II
·Terminated·Intersurgical Inc·July 4, 2018
Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalog #8003001, 4) medium adult size 4 catalog #8004001 and 5) large adult size 5 catalog #8005001 Patent airway management.
FDA Enforcement
Class II
·Terminated·Intersurgical Inc·December 13, 2017
Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector.
FDA Enforcement
Class II
·Terminated·Intersurgical Inc·January 15, 2020
Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.
FDA Enforcement
Class II
·Terminated·Intersurgical Inc·January 15, 2020
Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030. Airway connector.
FDA Enforcement
Class II
·Terminated·Intersurgical Inc·January 15, 2020
Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airway connector.
FDA Enforcement
Class II
·Terminated·Intersurgical Inc·January 15, 2020
Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems - Product Usage: intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
FDA Enforcement
Class II
·Terminated·Intersurgical Inc·January 6, 2021
Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
FDA Enforcement
Class II
·Terminated·Intersurgical Inc·October 26, 2022