7 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IRIS OCULIGHT SL DIODE LASER PHOTOCOAG/MODIFIED
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION
FDA 510(k)
FDA Class 2
·Cardiovascular
ORIGEN DUAL LUMEN CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·June 30, 2014
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 14, 2012
PFC SIGMA FEM STEM BOLT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·November 12, 2010
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