10 results
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16ms
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Sources: EU EUDAMED, US FDA
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Classification: Class I
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Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOLUME: 150mL, 2 mL/hr continuous Delivery Time : App. 72 hrs when filled to capacity Sterile EO... found in the following GoPump Kits: GoPump Kit 510042, w/ Epidural Catheter GoPump Kit 510042 - BP, w/ Epidural Catheter, BIOPATCH GoPump Kit 510110, w/2.5" Fenestrated Catheter GoPumpKit 510110-BP, w/2.5" Fenestrated Catheter,BioPatch GoPumpKit 510350 w/ Epidural Catheter GoPump Kit 510350-BP w/ Epidural Catheter, BIOPATCH GoPumpKit 510556-BP , 2.5 catheter, BIOPATCH Symbios GOPump Rapid Recovery System is a local pain mangagement system that consits of a small balloon that is inflated with a local anesthetic medication.
FDA Enforcement
Class I
·Terminated·Symbios Medical Products, LLC·June 12, 2013
INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025
Model Number S702, ALTRUA 2 DR SL Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025