10 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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SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
Pratt Dilator
FDA UDI
MEDGYN PRODUCTS, INC.·M803030858·Pratt Dilator 41-43 Fr (13.5-14.2 mm)
MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175
FDA 510(k)
FDA Unclassified
·Unknown
WEHRS INCUS-STAPES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·September 17, 2013
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·March 28, 2013
ICEMAN THERAPY UNIT
FDA Adverse Event
Injury
·DJ ORTHOPEDICS DE MEXICO·Product code ILO·March 21, 2011
DYNESYS HA PEDICLE+SET SCREW 6.4 X 55
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code NQP·April 9, 2008
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024