9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONTACT LASER & DIAGNOSTIC LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 1, 2020
HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST
FDA 510(k)
FDA Class 1
·Dental
IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET
FDA 510(k)
FDA Class 2
·Orthopedic
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·March 27, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·March 13, 2014
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION DIV.·Product code LGW·February 15, 2011
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