11 results
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21ms
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Sources: EU EUDAMED, US FDA
X-SCRIBE II
FDA 510(k)
FDA Class 2
·Cardiovascular
18PG - Eye Wash Station WC
FDA UDI
Certified Safety Manufacturing, Inc.·00766588226187·18PG - Eye Wash Station WC
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113829·PS-C Insert, Size 6 x 18mm
AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL
FDA 510(k)
FDA Class 2
·Hematology
OSA RIGID INTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
HLS MODULES
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·March 20, 2013
HYDRAJAGWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA·Product code EZB·March 17, 2011
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 31, 2008
VERTECEM V+ CEMENT KIT
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NDN·November 6, 2018
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
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018