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

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HOFFMANN 3

FDA 510(k)
FDA Class 2 ·Orthopedic

CoRoent

FDA UDI
Nuvasive, Inc.·00887517564696·CoRoent Ant TLIF PEEK, 12x12x28mm 4°

SNORE-AID MAX

FDA 510(k)
FDA Class 2 ·Dental

KRYSTALRAD 560 (FLAATZ 560)

FDA 510(k)
FDA Class 2 ·Radiology

WAVEWRITER ALPHA 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 16, 2024

PROFEMUR(R) Z STEM PLASMA SPRAYED

FDA Adverse Event
Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·May 21, 2013

ENRHYTHM DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code DXY·June 13, 2011

LIGHTWAVE SUCTION ABLATOR

FDA Adverse Event
Malfunction ·CONMED LINVATEC·Product code GEI·August 13, 2008

ATLAS GOLD

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 18, 2023

ATLAS GOLD

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 7, 2023

ATLAS GOLD

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·November 14, 2023

SAFESHEATH II 9F

FDA Adverse Event
Malfunction ·OSCOR INC.·Product code DYB·August 10, 2022

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022