12 results · 23ms · Sources: EU EUDAMED, US FDA

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DU PONT COMPACT DAYLIGHT SYSTEM II (CDS II)

FDA 510(k)
FDA Class 2 ·Radiology

CMI VACUUM PUMP

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

MORSE(R) ANGIOGRAPHIC CATHETERS

FDA 510(k)
FDA Class 2 ·Cardiovascular

OMNIFIT SER. II INSERT-10 DEG.

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·January 22, 2013

MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·December 7, 2010

OT VERIO SYNC METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 10, 2014

SWAN-GANZ CONTINUOUS CARDIAC CATHETER

FDA Adverse Event
Death ·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011

SWAN-GANZ CONTINUOUS CARDIAC CATHETER

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011

SWAN-GANZ CONTINUOUS CARDIAC CATHETER

FDA Adverse Event
Death ·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011

SWAN-GANZ CONTINUOUS CARDIAC CATHETER

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011

BD PYXIS¿ MEDSTATION¿ ES

FDA Adverse Event
Malfunction ·CAREFUSION 303, INC.·Product code BRY·March 31, 2025

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