13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES
FDA 510(k)
FDA Class 1
·Cardiovascular
OTO-CEM
FDA 510(k)
FDA Class 2
·Dental
MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 28, 2019
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code MEB·August 23, 2021
CE INFUSOR LV 2, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 14, 2010
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 8, 2013
CONTOUR CURVED CUTTER STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 6, 2011
SYNTHES ATB ANTERIOR LUMBAR INTERBODY LUMBAR TRAY
FDA Adverse Event
Malfunction
·SYNTHES USA, INC.·Product code HXX·April 30, 2008
CE INFUSOR SV 2, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·March 10, 2010
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 2019
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018