13 results
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19ms
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Sources: EU EUDAMED, US FDA
DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108
FDA 510(k)
FDA Class 2
·Clinical Toxicology
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809844894·FOR MEN 20-30 MM HG KNEE HIGH CLOSED TOE LARGE-...
OMNI Knee
FDA UDI
Omni Life Science, Inc.·00841690111740·Modular Tibia Augment Bolt Size 8mm
Verifine
FDA UDI
Promisemed Medical Devices Inc.·00850011833575·The proposed device Insulin Syringe, a sterile ...
Verifine
FDA UDI
Promisemed Medical Devices Inc.·00850011833773·The proposed device Insulin Syringe, a sterile ...
RESPIRONICS
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, LLC·Product code MNS·June 8, 2021
BIOSUC
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
RESPIRONICS
FDA Adverse Event
Malfunction
·Product code MNT·May 19, 2021
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 11, 2013
EVEREST BIPOLAR BICOAG
FDA Adverse Event
Malfunction
·GYRUS MEDICAL, INC.·Product code GEI·May 16, 2008
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 13, 2011
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