12 results
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25ms
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Sources: EU EUDAMED, US FDA
REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351
FDA 510(k)
FDA Class 3
·Cardiovascular
nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·10852417003696·KoKo Standard White Filter Kit with Nose Clip a...
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809848908·FOR MEN 15-20 MM HG KNEE HIGH OPEN TOE EXTRA LA...
SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876
FDA 510(k)
FDA Class 2
·Anesthesiology
MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 11, 2013
TOTAL CARE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·March 16, 2011
GEMSTAR7 THERAPY PUMP
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·May 22, 2008
Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 8, 2012
High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 8, 2012
Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 8, 2012
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