19 results
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37ms
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Sources: EU EUDAMED, US FDA
EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital
MICRUS MICROCATHETER, MODEL COURIER 270
FDA 510(k)
FDA Class 2
·Cardiovascular
DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
FDA 510(k)
FDA Class 2
·Neurology
MICROTAINER SST GOLD
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·June 7, 2018
BD MICROTAINER® EDTA LAVENDAR TUBES
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·May 1, 2018
BD MICROTAINER® EDTA LAVENDAR TUBES
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·May 16, 2018
ACTIVA
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 8, 2013
MICROTAINER SST GOLD
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD·Product code JKA·May 7, 2018
BD MICROTAINER® EDTA LAVENDER TUBES
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·April 27, 2018
BD MICROTAINER® EDTA LAVENDAR TUBES
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·May 3, 2018
BD MICROTAINER® BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·December 3, 2017
CORMET RESURFACING
FDA Adverse Event
Other
·CORIN MEDICAL, LTD.·Product code NXT·March 1, 2013
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·February 15, 2011
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·August 8, 2014
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·August 7, 2014
ACTIVA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code MHY·August 9, 2012
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·September 9, 2015
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·November 15, 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