12 results
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19ms
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Sources: EU EUDAMED, US FDA
CARRIAZO PENDULAR
FDA 510(k)
FDA Class 1
·Ophthalmic
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032910·Baltic Denture System BDLoad Mm6 PLSEbim6DFm B3...
THE BIOPLATE MANDIBLE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
HOLY DRAGON ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
AVALUS AORTIC TISSUE VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 23, 2020
LOGIC TIBIA IMPLANT PSC INSERT, SZ 6, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 22, 2024
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 3, 2013
ACCU-CHEK ® INFORM BASE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·March 29, 2011
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD.·Product code KWB·April 23, 2008
LOGIC FEMORAL PS CEM RIGHT SZ 6
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·August 9, 2024
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