13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PeraServer and PeraTrend
FDA 510(k)
FDA Class 2
·Cardiovascular
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970560·
MS SYSTEM (DENTURE)
FDA 510(k)
FDA Class 2
·Dental
PROLYTE ELECTROLYTE ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973479·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970881·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973080·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973707·
CURLIN INFUSION IV PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICE GROUP·Product code FRN·May 30, 2013
ACUITY CATHETER
FDA Adverse Event
Injury
·GUIDANT PUERTO RICO BV·Product code DYB·July 23, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN BENNETT CORP·Product code CBK·September 19, 2008
UNITIP CATHETER FOR HR GI
FDA Adverse Event
Injury
·UNISENSOR AG·Product code FFX·August 25, 2014
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022