8 results
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18ms
·
Sources: EU EUDAMED, US FDA
CONVERTORS FLASH STERILIZING TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EasyTouch
FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC18321371·
PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MULTISTIM
FDA 510(k)
FDA Class 2
·Physical Medicine
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·May 27, 2014
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 14, 2012
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR - VASCULAR SOLUTIONS·Product code MGB·September 3, 2010
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022