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

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OP-CON SURGICAL INSTRUMENT #9

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

ReLine

FDA UDI
Nuvasive, Inc.·00195377018908·RELINE-C Screw, 4.5x40mm

BIOMET ARCOM ALL POLY PAT BUTTON

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·February 24, 2017

VANGUARD CR-LIPPED TIBIAL BEARING 10MM X 79/83MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·February 24, 2017

Zavation

FDA UDI
Zavation LLC·00842166192683·Modular Screw 4.5 x 40

Zavation

FDA UDI
Zavation LLC·00842166193949·Modular Screw 4.5 x 40

RENNCO MODEL LS LIFT SEAL HEAT SEALER

FDA 510(k)
FDA Class 2 ·General Hospital

COMPRESSOGRIP ELASTIC STUMP SHRINKER#

FDA 510(k)
FDA Class 1 ·Physical Medicine

1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 9MM STOP

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HBE·September 2, 2020

DEKNATEL BON GN BR 2-0 C-2/CST-43

FDA Adverse Event
Malfunction ·TELEFLEX·Product code GAK·March 19, 2014

ATTAIN ABILITY

FDA Adverse Event
Malfunction ·MPRI·Product code OJX·June 10, 2015

TERUMO CDI 500 BLOOD PARAMETER MONITOR

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DRY·September 9, 2010

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