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

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SHARPSAWAY II LOCKING DISPOSABLE CUP

FDA 510(k)
FDA Class 2 ·General Hospital

Exact Medical Manufacturing, Inc.

FDA UDI
EXACT MEDICAL MANUFACTURING, INC.·06975424196421·Cover, Holding Systems

ALANTE, BATTERY OPERATED POWER WHEELCHAIR

FDA 510(k)
FDA Class 2 ·Physical Medicine

MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM

FDA 510(k)
FDA Class 2 ·Neurology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 19, 2025

ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MRG·August 14, 2013

ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LGD·September 18, 2013

ADVIA CENTAUR TSH3-ULTRA (TSH3-UL)

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JLW·April 30, 2014

FLEXTEND II

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVN·April 8, 2013

FLEXTEND

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVN·April 6, 2011

DST SERIES EEA ORVIL 25MM DEVICE

FDA Adverse Event
Injury ·NORTH HAVEN - USS·Product code GDW·May 12, 2008

ADVIA CENTAUR XP

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code NHS·January 31, 2014

The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

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