11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Bosworth Superbite
FDA UDI
Harry J Bosworth Company·H66809218161·ZOE Bite Regist. Paste Base
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123274·K-WIRE - DOUBLE TROCAR 1.8mm DIA x 150mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123137·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 150mm
Wesper Lab
FDA 510(k)
FDA Class 2
·Anesthesiology
SENSUS ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
SHARPS CONTAINER
FDA Adverse Event
Malfunction
·POST MEDICAL, INC.·Product code FMI·March 12, 2024
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 14, 2013
TEMPORARY BIPOLAR MYOCARDIAL PACING LEAD
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES, INC.·Product code LDF·December 6, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·February 6, 2014
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022