12 results
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20ms
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Sources: EU EUDAMED, US FDA
FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01
FDA 510(k)
FDA Class 2
·Cardiovascular
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014606613·MIDMARK MONTREAL 2.25" SOFTCARE PLUS
Conformis Hip System
FDA UDI
Conformis, Inc.·00850268007897·REAMER HANDLE SLEEVE
ACCU-SPACE ABSORBABLE SEEDING SPACERS
FDA 510(k)
FDA Class 2
·Radiology
SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·August 13, 2014
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 5, 2024
SMALL PERIPHERAL CUTTING BALLOON¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LOX·April 26, 2013
AIR OPTIX AQUA
FDA Adverse Event
Injury
·CIBA VISION JOHORE SDN. BHD·Product code LPM·April 25, 2011
QUANTUM MAVERICK MR BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LOX·July 22, 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