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

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NASAL-SINUS PACKING

FDA 510(k)
FDA Class 1 ·Ear, Nose, Throat

GRASPING FORCEPS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT

FDA 510(k)
FDA Class 2 ·Orthopedic

GOBED II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·January 22, 2013

CONCERTO CRT-D DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code NIK·December 14, 2010

OT VERIO PRO 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

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