15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
TEXIUM SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
BD TEXIUM¿ NEEDLE-FREE SYRINGE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FMF·November 29, 2022
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704292558·
NA
FDA UDI
KEY SURGICAL, INC.·10849771048913·K-Wires, Double trocar, .054-inch (1.4mm) diame...
K-Wire w. double end trocarpoint 1.40mm/127mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM711080·K-Wire w. double end trocarpoint
1.40mm...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484092·K-Wire w. double end trocarpoint _x000D_...
CONMED
FDA UDI
Conmed Corporation·10845854000342·GRAFT HARVESTING BLADE 8 X 20 MM
ESOP HA FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL
FDA 510(k)
FDA Class 2
·Dental
FULL FACE MASK
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code MNT·June 4, 2008
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·April 22, 2013
OTHER
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·April 27, 2011
DEPUY
FDA Adverse Event
Injury
·DEPUY MANUFACTOR·Product code JDI·July 7, 2008
GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·July 30, 2014
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