18 results · 30ms · Sources: EU EUDAMED, US FDA

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DIGITAL RADIOGRAPHY CXDI-60C

FDA 510(k)
FDA Class 2 ·Radiology

PIPET CURET

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

VERDICT -II TCA, VERDICT-II MTD

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 18, 2024

BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·August 7, 2019

DURATA STS OPTIM PASSIVE FIXATION LEAD

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL INC., CRMD·Product code NVY·January 13, 2014

ANESTAR ANESTHESIA SYSTEM

FDA Adverse Event
Malfunction ·MINDRAY DS USA, INC.·Product code BSZ·April 30, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·May 17, 2011

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·November 20, 2017

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·November 10, 2017

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·September 17, 2020

UNFOLDER PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·AMO PUERTO RICO MFG. INC.·Product code KYB·August 9, 2021

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·March 24, 2016

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·April 4, 2018

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code KYB·April 24, 2018

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code KYB·April 2, 2018

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·AMO PUERTO RICO MFG. INC.·Product code KYB·January 11, 2021

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