9 results · 24ms · Sources: EU EUDAMED, US FDA

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VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage

FDA 510(k)
FDA Class 2 ·Radiology

LANEX Regular Screens

FDA UDI
CARESTREAM HEALTH, INC.·60889971241436·PR 30X35CM LANX SCR R C2 W/O FOAM

SAS INFLUENZA B TEST

FDA 510(k)
FDA Class 2 ·Microbiology

ORTHODONTIC ACRYLIC (NOT FINALIZED)

FDA 510(k)
FDA Class 2 ·Dental

POLIGRIP CUSHION COMFORT

FDA Adverse Event
Injury ·ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH·Product code KOT·May 18, 2020

NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 19MM

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·November 10, 2014

LEAD MODEL 302

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·August 18, 2011

GYNECARE TVT OBTURATOR SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTN·July 22, 2013

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