12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·10852417003672·KoKo Standard Pulmonary Function Filter, White ...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776165888·Meyerding Retractor . . Blds
BREAS HA50 HUMIDIFIER, MODEL HA50
FDA 510(k)
FDA Class 2
·Anesthesiology
MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD
FDA 510(k)
FDA Class 2
·Cardiovascular
COLORADO 2 SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·January 22, 2009
COLORADO 2 SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWP·February 23, 2012
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code MMH·April 11, 2013
SM104 M-SERIES W/5TH WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·March 16, 2011
ANALYTICAL E MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·May 22, 2008
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 24, 2016
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