13 results · 17ms · Sources: EU EUDAMED, US FDA

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SMILJANIC BONE REPOSITIONING FORCEPS

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

XLX

FDA UDI
Nuvasive, Inc.·00887517944962·XLX ACR Expansion Driver, Std Inserter

SURGICAL ISOLATION GOWN

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

BIOLOX DELTA CERAMIC FEMORAL HEAD

FDA 510(k)
FDA Class 2 ·Orthopedic

HT70 PLUS VENTILATOR

FDA Adverse Event
Malfunction ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·April 16, 2014

SWEET PICOTIP

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVN·October 15, 2010

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·December 13, 2012

SINGLE FUNCTION ABC PENCIL, HAND CONTROL HANDPIECE

FDA Adverse Event
Malfunction ·CONMED ELECTROSURGERY·Product code HAM·September 11, 2015

BIOLOX HEAD HIP IMPLANT

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code JDI·April 25, 2019

ABC HANDPIECE LAPAROSCOPIC

FDA Adverse Event
Malfunction ·CONSOLIDATED MEDICAL EQUIPMENT·Product code HAM·February 19, 2019

UNKNOWN BIOLOX HEAD

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code LZO·February 13, 2018

CERASUL, HEAD, M/0, TAPER 12/14

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code JDI·November 4, 2019

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