12 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM
FDA 510(k)
FDA Unclassified
·Unknown
Vial Adaptor
FDA UDI
WEST PHARMA. SERVICES IL, . LTD·07290108240481·Vial Adapter 13mm FLL w/15μm Filter - SF
CM-hex screw system
FDA UDI
Cendres+Métaux SA·07640173093541·CM-hex screw system
Cap screw
Screw tap M1.4
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108694062·Step Drill Stop for L13mm Implant, Wide Long
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108697681·Titanium Base Abutment Round, Int. Hex. SP L6mm...
AutoPulse Battery
FDA UDI
Zoll Circulation, Inc.·00849111002097·Box containing Nickel-metal Hydride (NiMH) batt...
STERILE NITRILE POWDER-FREE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
BUILD-IT FR
FDA 510(k)
FDA Class 2
·Dental
NOVA MAX PLUS GLUCOSE MONITOR
FDA Adverse Event
Other
·NOVA BIOMEDICAL CORPORATION·Product code CGA·April 17, 2013
AFFINITY 4
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code HDD·June 30, 2008
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·April 27, 2011
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·October 8, 2014