11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TIMENTIN 85 MCG. SENSI-DISC
FDA 510(k)
FDA Class 2
·Microbiology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209105151·
Sklar
FDA UDI
SKLAR CORPORATION·10649111067976·OTIS BOUGIE A BOULE 22FR
St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Hand Massager (SM004D)
FDA 510(k)
FDA Class 2
·Physical Medicine
SROM*STM ST,36+8L NK,22X17X165
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code JDI·April 2, 2012
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 5, 2014
SYNERGY
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·November 29, 2012
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code DTB·September 28, 2010
CS Uni-Directional w Auto ID, Product Number D135303; 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