10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HOME CARE JELLY
FDA 510(k)
FDA Class 2
·Neurology
nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·10852417003672·KoKo Standard Pulmonary Function Filter, White ...
GDC POWER SUPPLY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - FREMONT·Product code HCG·July 20, 2010
MODIFICATION TO M2376A DEVICELINK SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4
FDA 510(k)
FDA Class 2
·Neurology
PELVISOFT ACELLULAR COLLAGEN BIOMESH
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTM·March 20, 2013
MX-PRO R-3 AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·February 15, 2011
MODULAR ANALYTICS CORE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·March 31, 2008
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
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