15 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED FLEX FIXED BEARING AND TIVANIUM TI-6AL-4V ALLOY FEMORAL
FDA 510(k)
FDA Class 2
·Orthopedic
HEMOSIL RECOMBI PLASTIN
FDA 510(k)
FDA Class 2
·Hematology
ACAPELLA
FDA 510(k)
FDA Class 2
·Anesthesiology
COVIDIEN
FDA Adverse Event
Other
·COVIDIEN·Product code GDW·April 11, 2013
TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
FDA Adverse Event
Other
·CARIDIANBCT·Product code LKN·April 8, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·June 18, 2008
BIOKNOTLESS ANCHORS
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code MBI·March 4, 2008
BIOKNOTLESS ANCHOR
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code MBI·March 4, 2008
BIOKNOTLESS ANCHOR
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code MBI·March 4, 2008
BIOKNOTLESS ANCHOR
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code MBI·March 4, 2008
BIOKNOTLESS ANCHOR
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code MBI·March 4, 2008
Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort 43", STD 5/5; Infusion Set, Comfort Short, 13mm x 23"; Infusion Set, Comfort Short, 13mm x 32"; Infusion Set, Comfort, 17mm x 32"' Infusion Set, Comfort Short, 13mm x 43"; Infusion Set, Comfort, 17mm x 43" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018