12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROLENE (Polypropylene) 3D Patch
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SONIC AIR MM1500 + (MID), MODEL 50400014
FDA 510(k)
FDA Class 2
·Dental
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·March 26, 2013
CONTOUR USB
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·December 14, 2012
CONTOUR NEXT
FDA Adverse Event
Injury
·BAYER HEALTHCARE LLC·Product code NBW·July 27, 2012
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 17, 2014
DHS/DCS-SCR Ø12.5 L85 SST
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KTT·June 21, 2013
FUSION NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 8, 2011
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·October 5, 2022
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I model is no longer produced, but the legacy humidifier bottle component design can also be used with the BT37 Mark II Benchtop Incubator.
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·October 5, 2022
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018