9 results
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17ms
·
Sources: EU EUDAMED, US FDA
MP4, MP4SI, IT4 INCUBATORS
FDA 510(k)
FDA Class 2
·General Hospital
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756229395·LAP CHOLE TRACEPAK®
GLUCO LAB AUTO CODING, MODEL IGM-0022
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MONARCH II IOL DELIVERY SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
OT VERIO PRO PLUS METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·November 10, 2010
URETEX SUPPORT PP TRANSOBTUR2 KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·October 31, 2012
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·February 15, 2017
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