9 results · 21ms · Sources: EU EUDAMED, US FDA

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HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03

FDA 510(k)
FDA Class 2 ·General Hospital

BI-3M NEEDLE-FREE INJECTOR SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

PCCR DIGITAL IMAGING DEVICE

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 21, 2025

NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 CUPS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·May 15, 2024

COGNIS

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 9, 2013

ENDOTAK RELIANCE SG

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

LIGAMAX-5MM

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 7, 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