12 results
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38ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HSB·January 22, 2017
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033618·Baltic Denture System BDLoad BDLoad Sw7 PLSEbm...
INTRAORAL MANDIBULAR DISTRACTION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014
FDA 510(k)
FDA Class 2
·Orthopedic
ECHOTIP CELIAC PLEXUS NEUROLYSIS NEEDLE
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code BSP·November 21, 2019
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·April 3, 2013
6 SHOOTER SAEED MULTI-BAND LIGATOR
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code MND·February 11, 2011
INTRATHECAL CATHETER
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code LKK·April 24, 2008
ECHOTIP ULTRA CELIAC PLEXUS NEUROLYSIS NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·July 5, 2023
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