16 results · 29ms · Sources: EU EUDAMED, US FDA

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MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT

FDA 510(k)
FDA Class 2 ·Cardiovascular

BIOPSY MEDIUM, MODEL REF 1062

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Kyphon HV-R Bone Cement

FDA 510(k)
FDA Class 2 ·Orthopedic

KYPHON HV-R BONE CEMENT

FDA Adverse Event
Injury ·MDT KYPHON NEUCHATEL MFG·Product code NDN·October 25, 2017

KYPHX® HV-R¿ BONE CEMENT

FDA Adverse Event
Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·April 7, 2017

KYPHX HV-R BONE CEMENT

FDA Adverse Event
Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·July 19, 2020

KYPHX® HV-R¿ BONE CEMENT

FDA Adverse Event
Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 4, 2019

KYPHX® HV-R¿ BONE CEMENT

FDA Adverse Event
Injury ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 17, 2017

KYPHX HV-R BONE CEMENT

FDA Adverse Event
Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·December 17, 2018

KYPHX® HV-R¿ BONE CEMENT

FDA Adverse Event
Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 7, 2017

KYPHX HV-R BONE CEMENT

FDA Adverse Event
Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·October 12, 2017

KYPHX HV-R BONE CEMENT

FDA Adverse Event
Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·July 9, 2020

S3 EX - 3005

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·February 14, 2013

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 22, 2014

EON MINI 16-CHANNEL IPG

FDA Adverse Event
Injury ·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·January 11, 2011

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