18 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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SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484443·K-Wire w. trocar/round end _x000D_...
Conmed/Linvatec
FDA UDI
Provision·00810041065841·
Conmed/Linvatec
FDA UDI
Provision·B504OM50711800·
K-Wire w. trocar/round end 0.89mm/152mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM711800·K-Wire w. trocar/round end
0.89mm...
NA
FDA UDI
STERILMED, INC.·10888551020541·SAW BLADE OSCILLATING LARGE BONE
CONMED
FDA UDI
Conmed Corporation·10845854006351·OSCILLATOR BLADE, 10 X 85 X 1.27 MM (.050")
TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528
FDA 510(k)
FDA Class 2
·Cardiovascular
CT/MASTER, VERSION 1.0
FDA 510(k)
FDA Class 2
·Radiology
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 19, 2026
TOTAL CARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 9, 2013
SIGMA 300 DR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code DXY·April 27, 2011
GE OEC 9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEM INC.·Product code JAA·July 10, 2008
BD TEXIUM¿ NEEDLE-FREE SYRINGE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FMF·November 29, 2022
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