8 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192473·Apex Revision Knee Reamer – ZIMMER LONG FLUTES,...
BASIS VERTEBRAL BODY SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra Fa
FDA 510(k)
FDA Class 2
·Orthopedic
MASTISOL LIQUID ADHESIVE
FDA Adverse Event
Injury
·FERNDALE LABORATORIES, INC.·Product code KGX·December 29, 2010
COULTER® ACT DIFF ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·February 8, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 22, 2014
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024