11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
8100/8500 VITAL SIGNS MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
AMT SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 26, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·March 21, 2014
LIGAMAX-5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·March 28, 2011
UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014 Femoral Component Size 4, 26016 Femoral Component Size 6, 26018 Femoral Component Size 8 and 26020 Femoral Component Size 10
FDA Recall
Terminated
·Plus Orthopedics USA·Product code HRY·July 18, 2006
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
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018