9 results
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18ms
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Sources: EU EUDAMED, US FDA
MODELS 4201, 4231 & 4235 EXTENSION CABLES
FDA 510(k)
FDA Class 2
·Cardiovascular
Brigade
FDA UDI
Nuvasive, Inc.·00887517457172·Brigade HL Trial, 6x34x24mm 25°
Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3
FDA 510(k)
FDA Class 2
·Radiology
6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351
FDA 510(k)
FDA Class 2
·General Hospital
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 1, 2021
NX3 DUAL CURE
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EMA·June 30, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-REDWOOD CITY·Product code MGB·November 18, 2010
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013
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