11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IV PREP KIT W/O DRESSING (NON-STERILE)
FDA 510(k)
FDA Class 2
·General Hospital
DePuy Songer Spinal Cable System
FDA UDI
Pioneer Surgical Technology, Inc.·10846468005358·Bar, Flex, Small, Ti, NS, AcroMed
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668110935·STERILIZING CASE NARROW
Solstice Occipito-Cervico-Thoracic System
FDA UDI
Life Spine, Inc.·00190837015176·
Songer® Spinal Cable System
FDA UDI
Pioneer Surgical Technology, Inc.·00840298704347·(1) Ø1.25mm Small Cable, Double Loop with Crimp...
LAB-SITE SAFETY NEEDLE
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCUSCREEN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Injury
·MEDTRONIC MILACA, INC.·Product code LWS·January 22, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 5, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 14, 2010
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024