14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARTHREX TENODESIS SCREW FAMILY
FDA 510(k)
FDA Class 2
·Orthopedic
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·October 30, 2017
ONTRAK TESTCUP PRO-5, MODEL 1986678
FDA 510(k)
FDA Class 2
·Clinical Toxicology
THE DIVACUP MENSTRUAL SOLUTION
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VERTE-STACK SPINAL SYSTEM
FDA Adverse Event
Malfunction
·SOFAMOR DANEK DEGGENDORF GMBH·Product code MQP·January 21, 2010
VERTE-STACK SPINAL SYSTEM
FDA Adverse Event
Malfunction
·SOFAMOR DANEK DEGGENDORF GMBH·Product code ODP·November 20, 2009
T25 STARDRIVE SHAFT F/MATRIX LONG
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HXX·April 8, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 23, 2011
INTRO-FLEX SHEATH INTRODUCER WITH AMC THROMBOSHIELD
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYB·May 8, 2008
BIOLOX DELTA CERAMIC TAPER LINER JJ / 36
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code LZO·September 2, 2022
HARMONY DELIVERY CATHETER SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPV·February 13, 2026
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