16 results
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27ms
·
Sources: EU EUDAMED, US FDA
RAPIDO CUT-AWAY GUIDING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704505726·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0315030·Probe, 1.5 inch Ball, Steffee, Curved, Impaction
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0315040·Probe, 1.5 inch Ball, Lenke, Straight, Impaction
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0310050·Probe, 1.5 inch Ball, Lenke, Curved, Black
IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AUROFLUID PLUS
FDA 510(k)
FDA Class 2
·Dental
EPIC?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code FGE·April 2, 2013
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·March 21, 2011
VERSTAILE 1 WOUND VACUUM SYSTEM
FDA Adverse Event
Other
·BLUESKY MEDICAL GROUP INC.·Product code GCY·August 14, 2007
2710 CLEARTRACE LT
FDA Adverse Event
Other
·CONMED CORPORATION·Product code GXY·April 13, 2007
BD, Salmonella Flagellar d Antigen (Typhoid H)
FDA Recall
Terminated
·BD Diagnostic Systems·Product code GNC·October 20, 2004
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
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016