10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BD MAX Vaginal Panel
FDA 510(k)
FDA Class 2
·Microbiology
Oticon
FDA UDI
Oticon A/S·05707131340085·SIYA 2, KIT 312 2.4G NFM 90 PB L C001
Sklar®
FDA UDI
SKLAR CORPORATION·10649111386527·LANE TISSUE FCP 2X3 5 1/2"
POLARIS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT
FDA 510(k)
FDA Class 2
·Anesthesiology
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Injury
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 2, 2026
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 27, 2013
ACCENT DR RF
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 13, 2014
WURZBURG MINI SCREWS, C-F, S-T, 1.7X8
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS FREIBURG·Product code JEY·July 22, 2011
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020