10 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PENUMBRA SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Symmetry Cushing
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482052808·Symmetry® Forceps, Cushing Bayonet Tissue, 1x2 ...
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB
FDA 510(k)
FDA Class 1
·General Hospital
COCR FEMORAL HEAD
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·February 23, 2018
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 23, 2013
DEPUY PINNACLE
FDA Adverse Event
Injury
·Product code JDI·April 25, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
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