5 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.
FDA Enforcement
Class I
·Terminated·ICU Medical, Inc.·April 24, 2019
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
FDA Recall
Terminated
·Mako Surgical Corporation·Product code OLO·December 22, 2016
Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code MBI·May 31, 2016
Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) articular Intercarpal fracture dislocations Unstable forearm fractures Unstable elbow dislocation Multiple extremity fractures Radial osteotomies Foot and ankle fractures Paediatric fractures
FDA Recall
Terminated
·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code JEC·November 21, 2019
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015