11 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306819445·Custom right angle Finger Retractor, 11.5cm x 3...
PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30)
FDA 510(k)
FDA Class 1
·General Hospital
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·December 14, 2012
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 14, 2013
ACCURUS 800CS
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·March 31, 2011
9617604-2008-00098
FDA Adverse Event
Injury
·Product code BSY·August 4, 2008
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
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021