12 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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SPACELINE HIGH VOLUME EVACUATION HANDPIE
FDA 510(k)
FDA Class 1
·Dental
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450053102·
Symmetry Rhoton®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482031407·Rhoton® Dissector, Penfield, Etched Label #3, L...
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209132294·
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776354978·R-Type dissector
ACUMED
FDA UDI
Acumed LLC·10806378050992·Half-Size Single Level Case Base ASSY
VSCORE WITH EKG SIGNAL GATING
FDA 510(k)
FDA Class 2
·Radiology
S 100 PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·April 25, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·October 23, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 27, 2007
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