30 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
Unity Total Knee System
FDA UDI
CORIN LTD·05055343897720·Tibial Augment 5mm RM-LL size 1
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772813827·GENUMEDI PRO SILVER SIZE II
ICU Medical
FDA UDI
ICU MEDICAL, INC.·00840619043704·TD Catheter, 8F, 5 lumen, 110cm, RA/RV, Heparin...
TAPERLOC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304282186·
TD 5 LUMEN HEPARIN COATED CATHETER
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code DYG·December 31, 2015
8F TD CATHETER
FDA Adverse Event
ICU MEDICAL, INC.·Product code DYG·August 24, 2015
8F TD TORQUE-LINE CATHETER
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FPA·April 7, 2015
8F TD CATHETER
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code DYG·April 14, 2015
8F TD CATHETER
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code DQE·July 2, 2015
K2M General Instruments
FDA UDI
VB Spine LLC·10888857552043·Polyaxial Screwdriver Shaft
PREASSEMBLED SURGICAL WASH SET
FDA 510(k)
FDA Class 2
·Anesthesiology
MICROSCAN SYNERGIES PLUS
FDA 510(k)
FDA Class 2
·Microbiology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·April 13, 2023
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 19, 2020
ISITE PACS
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·November 18, 2008
PREFYX PPS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FTL·May 21, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
NOVOSYN VIOLET7/0(0.5)45CM2XDLM6S200M
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·January 9, 2024
Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019