33 results
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47ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Oscilla
FDA UDI
Inmedico A/S·05713557000113·
Oscilla
FDA UDI
Inmedico A/S·05713557000120·
Oscilla
FDA UDI
Inmedico A/S·05713557000106·
Oscilla
FDA UDI
Inmedico A/S·05713557000090·
Oscilla
FDA UDI
Inmedico A/S·05713557000014·
Oscilla
FDA UDI
Inmedico A/S·05713557000083·
Oscilla
FDA UDI
Inmedico A/S·05713557000052·
Oscilla
FDA UDI
Inmedico A/S·05713557000069·
Oscilla
FDA UDI
Inmedico A/S·05713557000076·
Oscilla
FDA UDI
Inmedico A/S·05713557000021·
Oscilla
FDA UDI
Inmedico A/S·05713557000038·
Oscilla
FDA UDI
Inmedico A/S·05713557000045·
IMPELLA CP
FDA Adverse Event
Injury
·ABIOMED, INC.·Product code OZD·November 6, 2023
SYNCHROMED III
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·May 1, 2025
BD MAXGUARD¿ EXTENSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 9, 2023
BD MAXGUARD EXTENSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 8, 2023
BD MAXGUARD¿ EXTENSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 23, 2023
RELIAVAC CLOSED WOUND SUCTION SYSTEM
FDA Adverse Event
Malfunction
·PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590·Product code GBX·March 23, 2017
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #15 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell 2215-L Weighted Safety Scalpel, #3L Handle (8.75) with #15 Blade, Yellow Shield with TIME OUT¿ Sleeve (S) 12 per box; 8 boxes per case (96 total scalpels) A manual surgical scalpel blade for making incisions in various general surgical procedures.
FDA Enforcement
Class II
·Terminated·Ansell Sandel Medical Industries LLC·January 15, 2014
EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI): EZC21A (00690103174182), EZC21TA (00690103174199), EZC24A (00690103714401), EZC24TA (00690103714418), EZF21A (00690103175080), EZF21TA (00690103175097), EZF24A (00690103175066), EZF24TA (00690103175073), EZS21A (00690103172096), EZS21TA (00690103172102), EZS24A (00690103172119), and EZS24TA (00690103172126) Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Aortic cannulae in sizes 6 Fr. (2 mm) to 18 Fr. (6 mm) can be used in pediatric patient populations.
FDA Enforcement
Class II
·Terminated·Edwards Lifesciences, LLC·November 27, 2019