5 results
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16ms
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Sources: EU EUDAMED, US FDA
LCSU 4, 300 ml, Complete Unit (EUR)
FDA UDI
Laerdal Medical AS·07045432046663·The LCSU 4 is a portable, electrically powered,...
THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code GEI·July 19, 2019
Pentacam HR REF 70900. Used to image the anterior segment of the eye.
FDA Enforcement
Class II
·Ongoing·Oculus Optikgeraete GMBH·September 7, 2022
Laerdal Compact Suction Unit ¿ 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ml Complete unit (US), 88006103 - LCSU 4, 300 ml Complete unit (UK), 88006140 - LCSU 4, 300 ml Complete unit (EUR), 881151 - Replacement unit, 88006201 - LCSU 4, 300 ml, RTCA Complete unit (US), 88006203 - LCSU 4, 300 ml, RTCA Complete unit (UK), 88006240 - LCSU 4, 300 ml, RTCA Complete unit (EUR) and 881152 - Replacement Unit, RTCA; 2) 88005101 - LCSU 4, 800 ml Complete unit (US), 88005103 - LCSU 4, 800 ml Complete unit (UK), ¿ 88005140 - LCSU 4, 800 ml Complete unit (EUR), 88005201 - LCSU 4, 800 ml, RTCA Complete unit (US), 88005203 - LCSU 4, 800 ml, RTCA Complete unit (UK), 88005240 - LCSU 4, 800 ml, RTCA Complete unit (EUR) & 2) 800 ml (4.3 lbs) canister version - CATALOG #(s): 88005101, 88005201 (RTCA)
FDA Enforcement
Class II
·Terminated·Laerdal Medical Corporation·April 26, 2017
Laerdal Compact Suction Unit 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ml Complete unit (US), 88006103 - LCSU 4, 300 ml Complete unit (UK), 88006140 - LCSU 4, 300 ml Complete unit (EUR), 881151 - Replacement unit, 88006201 - LCSU 4, 300 ml, RTCA Complete unit (US), 88006203 - LCSU 4, 300 ml, RTCA Complete unit (UK), 88006240 - LCSU 4, 300 ml, RTCA Complete unit (EUR) and 881152 - Replacement Unit, RTCA; 2) 88005101 - LCSU 4, 800 ml Complete unit (US), 88005103 - LCSU 4, 800 ml Complete unit (UK), 88005140 - LCSU 4, 800 ml Complete unit (EUR), 88005201 - LCSU 4, 800 ml, RTCA Complete unit (US), 88005203 - LCSU 4, 800 ml, RTCA Complete unit (UK), 88005240 - LCSU 4, 800 ml, RTCA Complete unit (EUR) & 2) 800 ml (4.3 lbs) canister version - CATALOG #(s): 88005101, 88005201 (RTCA)
FDA Recall
Terminated
·Laerdal Medical Corporation·Product code JCX·January 8, 2017