12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPIROSOFT
FDA 510(k)
FDA Class 2
·Anesthesiology
Q-RAD System
FDA UDI
CARESTREAM HEALTH, INC.·60889971031198·Q-RAD SYSTEM/QG-6500-3-R10-T920V
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0311930·Probe, 1.75 inch, Egg, Steffee, Long, Curved
STERICHEK TOTAL CHLORINE REAGENT STRIPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNIMARK HCG COMBO PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MARKERS
FDA Adverse Event
Malfunction
·PRAXIM·Product code HAW·January 3, 2007
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 4, 2013
BRAVO PH MONITORING SYSTEM AND ACCESSORIES
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·March 17, 2011
ZENITH AAA ILIAC LEG GRAFT
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·April 16, 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
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