15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DELUXE WOUND CLOSURE TRAY, STERILE, DISPOSABLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772813841·GENUMEDI PRO SILVER SIZE IV
VITROS
FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750000265·VITROS Chemistry Products Mg Slides
Couture Essence
FDA UDI
Carolon Company·00078301981243·
Couture Essence
FDA UDI
Carolon Company·00078301921249·
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123069·K-WIRE - DOUBLE TROCAR 1.0mm DIA x 100mm
Excipio SV Thrombectomy Device
FDA 510(k)
FDA Class 2
·Cardiovascular
OLYMPUS BF TYPE UM40
FDA 510(k)
FDA Class 2
·Radiology
BI-METRIC HIP LATERALISED FEMORAL STEM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·March 2, 2017
PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·October 9, 2019
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code MTA·January 17, 2013
ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·December 9, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 9, 2014
VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 1921204 VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·November 27, 2013
VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 1921204 VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JGJ·June 12, 2013