10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN
FDA 510(k)
FDA Class 2
·Dental
Pratt Dilator
FDA UDI
MEDGYN PRODUCTS, INC.·M803030859·Pratt Dilator 9-11 Fr (3-3.6 mm)
OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1
FDA 510(k)
FDA Class 2
·Anesthesiology
THE LIBERATOR WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·August 26, 2019
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·March 28, 2013
M2A MAGNUM PF CUP
FDA Adverse Event
Injury
·BIOMET·Product code KWA·March 23, 2011
DUROM ACETABULAR COMPONENTS
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·April 9, 2008
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013
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