13 results
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20ms
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Sources: EU EUDAMED, US FDA
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