8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OXYMIZER-PENDANT
FDA 510(k)
FDA Class 2
·Anesthesiology
INSTRUMENT GUARD CAPSULE
FDA 510(k)
FDA Class 2
·General Hospital
POTASSIUM ANALYZER-SODIUM/ELECTROLYTE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 28, 2014
MAMMOTOME CONTROL MODULE WITH SMARTVAC - 120V
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code KNW·December 11, 2007
PROMOTE RF CRT-D
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·November 15, 2012
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015