11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BENCO ADMIX
FDA 510(k)
FDA Class 2
·Dental
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032152·Baltic Denture System BDLoad Sw7 PLSEbm6DFs A2l...
SlimLine®
FDA UDI
ZIMMER SPINE, INC.·00889024403970·
TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION
FDA 510(k)
FDA Class 2
·Dental
DS30 HCY BLOOD COLLECTION TUBES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MESH - VENTRALEX
FDA Adverse Event
Malfunction
·DAVOL INC.·Product code FTL·March 6, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·March 28, 2011
ESPRIT VENTILATOR
FDA Adverse Event
Injury
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·April 21, 2008
UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014 Femoral Component Size 4, 26016 Femoral Component Size 6, 26018 Femoral Component Size 8 and 26020 Femoral Component Size 10
FDA Recall
Terminated
·Plus Orthopedics USA·Product code HRY·July 18, 2006
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 TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016