12 results
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20ms
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Sources: EU EUDAMED, US FDA
VERISUITE 1.6, VERISUITE-PARTICLE 1.6
FDA 510(k)
FDA Class 2
·Radiology
ADARA
FDA UDI
HNM TOTAL RECON LLC·00841742102818·ADARA ø4.5mm Cortical Screw, Full Thread, SS - ...
MOSS MIAMI 5.5MM TITANIUM PIN NUT
FDA 510(k)
FDA Class 2
·Orthopedic
SYNTHES ANTERIOR CSLP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TVT DEVICE WITH PROLENE TAPE
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·November 4, 2019
GII ARTICULAR INSERTER/EXTRACT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBH·February 9, 2018
PERCLOSE PROGLIDE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·April 9, 2025
ARCHITECT CA 19-9XR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code NIG·April 26, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 6, 2011
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·July 23, 2008
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 2110. 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