15 results
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47ms
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Sources: EU EUDAMED, US FDA
PM International LLC
FDA registration
PM International LLC·2 products·🇺🇸 United States
SERV-U
FDA Adverse Event
Injury
·MAQUET CRITICAL CARE AB·Product code CBK·June 28, 2019
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·May 23, 2018
Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion.
FDA Recall
Terminated
·Genesis BPS, LLC.·Product code BRZ·July 17, 2014
Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
FDA Recall
Terminated
·Genesis BPS, LLC.·Product code BRZ·July 17, 2014
Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
FDA Recall
Terminated
·Genesis BPS, LLC.·Product code BRZ·July 17, 2014
Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
FDA Recall
Terminated
·Implant Direct Sybron Manufacturing LLC·Product code DZE·October 11, 2019
NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
FDA Recall
Open, Classified
·Beeken Biomedical, LLC·Product code POD·October 14, 2021
sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 35700BAXR, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Sigma, LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended.
FDA Recall
Terminated
·Baxter Healthcare Corp.·Product code FRN·September 28, 2016
V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended. Product Code 35701 is a replacement assembly that is shipped to customers for self-repair of the Spectrum Infusion Pump. It is not a registered finished good.
FDA Recall
Terminated
·Baxter Healthcare Corp.·Product code FRN·September 28, 2016
Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;
FDA Recall
Open, Classified
·Telcare, LLC·Product code NBW·January 30, 2025
MedEnvoy Global BV
Authorized representative
🇳🇱 Netherlands·143 Manufacturers·2306 Devices
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
CRITICAL HEALTHCARE LIMITED
Importer
🇮🇪 Ireland·69 Manufacturers
RIOMAVIX LTD
Authorized representative
🇪🇸 Spain·400 Manufacturers·4531 Devices