13 results · 23ms · Sources: EU EUDAMED, 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