12 results
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19ms
·
Sources: EU EUDAMED, US FDA
E-Z JECTOR
FDA 510(k)
FDA Class 2
·Dental
Equa-Pull
FDA UDI
LANCER ORTHODONTICS, INC.·00817573023806·EQUA-PULL HEADGEAR BLACK HEAVY
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127020674·Full Hemisphere Reamer Size 42
EliA CoV Positive Control C1 250
FDA UDI
Phadia AB·07333066021232·EliA CoV Positive Control C1 250
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code OYC·February 22, 2018
Q-Rejuvalight Pro Facewear (Model: P19-0023)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PREMIER III PHASED ARRAY CTL SPINE COIL
FDA 510(k)
FDA Class 2
·Radiology
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES·Product code LZG·May 1, 2014
PULSE GEN MODEL 103
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·November 13, 2012
TBL COMPONENT, BASIC TABLE WITH SEAT SECTION
FDA Adverse Event
Malfunction
·STRYKER COMMUNICATIONS·Product code FQO·September 7, 2010
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·June 29, 2017
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