6 results
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23ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Version 4.0.x (4.0.1052). Includes the below product descriptions: 1. ADAPTOR 64001 1X4 MVMT POCKET ADAPTOR, 2. ADAPTOR 64002 2X4 MVMT POCKET ADAPTOR, 3. INS 37602 Activa SC Neurostimulator, 4. INS 37603 Activa SCx Neurostimulator, 5. INS B35200 DBS PERCEPT PC, 6. INS B35300 PERCEPT RC V1
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code MHY·May 15, 2024
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
FDA Recall
Open, Classified
·Terumo Cardiovascular Systems Corporation·Product code DTZ·March 1, 2023
CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
FDA Recall
Open, Classified
·Terumo Cardiovascular Systems Corporation·Product code DTZ·March 1, 2023
CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
FDA Recall
Open, Classified
·Terumo Cardiovascular Systems Corporation·Product code DTZ·March 1, 2023
Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840
FDA Recall
Open, Classified
·Western/Scott Fetzer Company·Product code ECX·October 16, 2021
Medline procedural kits labeled as: 1) BABY CARE KIT UNIV, Pack Number DYKL1025; 2) BABY CARE KIT UNIV, Pack Number DYKL1025H
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code CCX·April 8, 2024