6 results
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12ms
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Sources: EU EUDAMED, US FDA
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK ENDO CURET W/BAS STER25, Model Number 96-4144A; 3) ECONO STERILE KEVORKIAN CURET W/O BAS STER25, Model Number 96-4145A; cervical biopsy
FDA Recall
Open, Classified
·Sklar Instruments·Product code HCY·December 3, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes intravascular ultrasound (IVUS). When used with a peripheral vascular imaging catheter, the system utilizes the IVUS modality for ultrasound examination of intravascular pathology.
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code DQK·September 5, 2024
PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.
FDA Recall
Open, Classified
·Envisiontec US Llc·Product code EBZ·January 20, 2022
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
FDA Recall
Open, Classified
·Atrium Medical Corporation·Product code GBZ·September 29, 2023
Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF Number: 15028
FDA Recall
Open, Classified
·Atrium Medical Corporation·Product code GBZ·April 21, 2022
Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Schein Inc., Melville, NY.
FDA Recall
Open, Classified
·Handpiece Headquarters·Product code EBZ·April 4, 2018