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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TSRH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LEONE SPA
FDA UDI
LEONE SPA·08033707065845·EXTRAORAL ELASTICS 3/8" 8 oz
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450439623·
QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LASER 3 SPSC300
FDA 510(k)
FDA Class 2
·Physical Medicine
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 3, 2013
SOFT DISC SHAVER (INSTRUMENT)
FDA Adverse Event
Malfunction
·MEDTRONIC·Product code HBB·September 10, 2014
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 3, 2011
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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018