16 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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UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526189751·LEVAMED ACTIVE ANKLE SUP BLACK L VI
ri-pen® blue
FDA UDI
Rudolf Riester GmbH·04045396120310·The Riester diagnostic light is used for ophtha...
Conmed/Linvatec
FDA UDI
Provision·00810041066138·
Conmed/Linvatec
FDA UDI
Provision·B504OM50715260·
NA
FDA UDI
STERILMED, INC.·10888551020756·SAW BLADE OSCILLATING LARGE BONE
HALL
FDA UDI
Conmed Corporation·10845854018828·LARGE BONE, HALL BLADE, OSCILLATING, 18.5 X 107...
HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123
FDA 510(k)
FDA Class 2
·Cardiovascular
ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 22, 2013
ASCENSIA CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·July 3, 2008
APEX HOLE ELIM POSITIVE STOP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code MRA·April 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 PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022