15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTERGRO ORAL
FDA 510(k)
FDA Class 2
·Dental
TruForm
FDA UDI
Rmo, Inc.·00885797099679·MAN MOLAR BDS PEDO ASST 100
TensCare
FDA UDI
TENSCARE LIMITED·05033435135776·The Nouri Digital Electric Breast Pump is a pow...
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290114690478·Final Drill for Ø3mm Implant, Long
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290114695091·Final Drill for Ø3mm Implant, Long
CTC DVT-1 CALF GARMENT, MODEL DVT-1
FDA 510(k)
FDA Class 2
·Cardiovascular
ENA EIA KIT
FDA 510(k)
FDA Class 2
·Immunology
OMNIGUIDE BEAMPATH FIBER AND ADAPTER
FDA Adverse Event
OMNIGUIDE, INC.·Product code GEX·October 19, 2010
PATIENT SAFETY NET
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code MSX·March 31, 2016
PATIENT SAFETY NET
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code MSX·March 31, 2016
5.0CM SHORT ATTACHMENT
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·April 15, 2013
SYNERGY
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code LGW·April 21, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 9, 2008
VERCISE CARTESIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·April 23, 2020
AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·February 18, 2015