17 results · 21ms · Sources: EU EUDAMED, US FDA

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LIAC HWL

FDA 510(k)
FDA Class 2 ·Radiology

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613043285·Phaco Slit Knife, Angled, 3mm Blade, Beveled Up...

MP Reconstruction Prosthesis

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575270583·Neck Segment,with collar

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613107857·Slit Knife, Angled, Guarded, 3mm Blade, Beveled...

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613055653·3.0mm Angled Phaco Blade Round Stock Single Bev...

MP Reconstruction Prosthesis

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575270576·Neck Segment,with collar

HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM

FDA 510(k)
FDA Class 2 ·Neurology

LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)

FDA 510(k)
FDA Class 2 ·Orthopedic

8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE® CLEAR, CHEMOLOCK¿ PORT, SPIROS®

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code ONB·January 27, 2020

8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE CLEAR, CHEMOLOCK PORT, SPIROS

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·August 26, 2020

VITALITY

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 23, 2011

EZ WAY CEILING LIFT GATE

FDA Adverse Event
Malfunction ·EZ WAY, INC.·Product code FNG·June 4, 2013

COLLEAGUE CX VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 25, 2008

AVENIR® MüLLER, STEM, STANDARD, UNCEMENTED, HA, 6, TAPER 12/14

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code LZO·March 7, 2025

RICKHAM RESERVOIR

FDA Adverse Event
Injury ·JOHNSON AND JOHNSON PROFESSIONAL, INC. / MEDOS S.A·Product code JXG·November 20, 2015

VENT RES TR RICKHAM LG BA

FDA Adverse Event
Injury ·CODMAN & SHURTLEFF, INC.·Product code JXG·May 15, 2015

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