8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE
FDA 510(k)
FDA Class 1
·General Hospital
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
FDA 510(k)
FDA Class 2
·Hematology
IBP ELB INT. ULNA LRG RGT LNG STM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDC·June 24, 2016
2520274-2013-01905
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·April 9, 2013
ISYMM ASPHERIC INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·HOYA SURGICAL OPTICS INC.·Product code HQL·February 25, 2011
CONTAK RENEWAL 3 RF
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 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