392 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·October 11, 2017
Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within the lung to a planned path in order to sample a target. User Manual: ION Endoluminal System, System, Instruments, and Accessories User Manual, PN 553990-05 REV. A 2019.12
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code EOQ·October 23, 2020
Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within the lung to a planned path in order to sample a target. User Manual: ION Endoluminal System, System, Instruments, and Accessories User Manual, PN 553990-05 REV. A 2019.12
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·December 2, 2020
Product 39 consists of all product under product code: JDI and same usage: Item no: 32902605800 ION IMPLANTED FEM 22MM LO 32902604900 ION IMPLANTED FEM 26MM ME 32902603900 ION IMPLANTED FEM 26MM SH For use in total or hemi hip arthroplasty
FDA Recall
Terminated
·Product code JDI·January 11, 2016
HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.
FDA Recall
Terminated
·Philips North America LLC·Product code MKJ·November 23, 2018
Product 39 consists of all product under product code: JDI and same usage: Item no: 32902605800 ION IMPLANTED FEM 22MM LO 32902604900 ION IMPLANTED FEM 26MM ME 32902603900 ION IMPLANTED FEM 26MM SH For use in total or hemi hip arthroplasty
FDA Enforcement
Class II
·Terminated·Zimmer Manufacturing B.V.·March 23, 2016
HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.
FDA Enforcement
Class II
·Terminated·Philips North America LLC·December 19, 2018
iPico Product Usage: Muscle stimulation
FDA Recall
Terminated
·Ion Genius, Inc.·Product code NFO·January 6, 2012
Perfector Product Usage: Muscle stimulation
FDA Recall
Terminated
·Ion Genius, Inc.·Product code IPF·January 6, 2012
Ion Magnum Product Usage: Muscle stimulation
FDA Recall
Terminated
·Ion Genius, Inc.·Product code IPF·January 6, 2012
IELLIOS Product Usage: Muscle stimulation
FDA Recall
Terminated
·Ion Genius, Inc.·Product code NFO·January 6, 2012
Arasys Product Usage: Muscle stimulation
FDA Recall
Terminated
·Ion Genius, Inc.·Product code IPF·January 6, 2012
Product is a lithium ion battery sold as both a stand-alone accessory, and as part of endoscopy system sets. Stand alone labeling: Vision Sciences Rechargeable Lithium Ion Batteries, Replacement (2) [REF] 07-3052; [MFG Symbol] Vision-Sciences, Inc., 40 Ramland Road South, Orangeburg, NY 10962 USA. Accessory to endoscopy kits used to charge/recharge lithium ion batteries.
FDA Recall
Terminated
·Vision-Sciences, Inc.·Product code EOB·December 27, 2011
Product is a lithium ion battery charger sold as both a stand-alone accessory, and as part of endoscopy system sets. --- Stand alone labeling: Vision Sciences Battery Charger, Lithium Ion [REF] 07-3051; [MFG Symbol] Vision-Sciences, Inc., 40 Ramland Road South, Orangeburg, NY 10962 USA. Accessory to endoscopy kits used to charge/recharge lithium ion batteries.
FDA Recall
Terminated
·Vision-Sciences, Inc.·Product code EOB·December 27, 2011
AmTryke Model 1424 Community Cruiser Hand Cycle. Therapeutic tricycle.
FDA Recall
Terminated
·Amtryke LLC·Product code ION·March 27, 2015
Norco Shoulder Pulley Distributed by North Coast Medical, Gilroy, CA. Used to improve range of shoulder movement and coordination following a stroke, shoulder injury or surgery.
FDA Recall
Terminated
·North Coast Medical Inc 8100 Camino Arroyo·Product code ION·July 11, 2011
Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·December 12, 2012
IMx Folate Ion Capture Component Set, list 2220-88; the set consists of 1 IMx Folate Reagent Pack, 100 tests, list 2220-20, and 100 Ion Capture reaction cells; Abbott Laboratories, Abbott Park, IL 60064 USA
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code CGN--·December 16, 2003
i-STAT EG7+ Cartridge; pH, PCO, PO, Na , K, iCa, Hct. Test include: Electrode Measurement Blood-Gases (Pco2, PO2) and Blood Ph, Electrode, Ion Specific, Potassium, Electrode, Ion Specific, Calcium, Electrode, ion Specific, Sodium and Hematocrit. Catalog number 220300. Abbott Point of Care inc., Abbott Park, IL 60064 USA Intended use is to quantify measurement of sodium, potassium, ionized calcium, oxygen, carbon dioxide, pH and Hematocrit in blood.
FDA Recall
Terminated
·Abbott Point of Care Inc.·Product code CHL·February 23, 2009
Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens Catalog Number: A32444
FDA Enforcement
Class II
·Terminated·Life Technologies Corporation·April 22, 2020