8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NON STERILE POWDER-FREE, NATURAL OR AQUA LANO-E NITRILE EXAMINATION GLOVES, WITH OR WITHOUT CITRUS/ PEPPERMINT SCENT
FDA 510(k)
FDA Class 1
·General Hospital
DELTA 32 AND DELTA 32 TACT
FDA 510(k)
FDA Class 2
·Radiology
A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 3, 2013
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 8, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 2011
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
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