9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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1.5T ATLAS SPEEDER HEAD-NECK COIL
FDA 510(k)
FDA Class 2
·Radiology
DRX5000
FDA 510(k)
FDA Class 2
·Physical Medicine
POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code MAX·April 29, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·April 13, 2011
CAMICROSTAAR FOAM TIP PLUNGER
FDA Adverse Event
Malfunction
·STAAR SURGICAL·Product code MSS·July 29, 2008
CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·August 29, 2018
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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024