10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Orthopedic
Conformis Hip System
FDA UDI
Conformis, Inc.·00850268007699·3.5MM DRILL GUIDE
NA
FDA UDI
STRYKER CORPORATION·07613327058567·PEEK Monopolar Handle
SPIFE IFE CALIBRATOR AND CONTROL KIT
FDA 510(k)
FDA Class 2
·Immunology
NSI HEXED AND NON-HEXED IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·April 26, 2013
EON MINI IPG, 16-CHANNEL RECHARGEABLE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·April 25, 2011
KIT 11.5FX19 .5CM MAHURKAR
FDA Adverse Event
Malfunction
·TYCO HEALTHCARE/KENDALL·Product code MSD·July 17, 2008
GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·July 30, 2014
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014