17 results · 21ms · Sources: EU EUDAMED, US FDA

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AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

DIGITAL BLOOD PRESSURE MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

Osom Ultra Plus Flu A&B Test Kit

FDA 510(k)
FDA Class 2 ·Microbiology

PROMUS ELEMENT ¿

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·August 11, 2015

ASR ACETABULAR IMPLANT 46

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·March 7, 2013

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MPRI·Product code DTB·August 8, 2014

CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code NKB·February 12, 2013

CLICKX PEDICSCR Ø6.2 L50 TAN DBLUE

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code NKB·February 12, 2013

CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code NKB·February 12, 2013

CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code NKB·February 12, 2013

CANNULA & CATHETER

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DWF·August 16, 2021

CANNULA & CATHETER

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DWF·September 7, 2020

CANNULA & CATHETER

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DWF·December 9, 2020

CANNULA & CATHETER

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DWF·April 25, 2022

CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DWF·June 5, 2020

CATHETERS & CANNULAE

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DWF·August 22, 2019

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