10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319741573·Anthony Suction Tube 6-1/2" (16.5cm), with 3mm ...
CIMARA
FDA 510(k)
FDA Class 2
·Dental
MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS
FDA 510(k)
FDA Class 2
·Microbiology
HEARTSTRING III PROXIMAL SEAL SYSTEM
FDA Adverse Event
Malfunction
·GUIDANT CARDIAC SURGERY·Product code DXC·October 6, 2008
CLINITRON RITEHITE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code INX·June 13, 2013
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·July 25, 2011
AURAGAIN
FDA Adverse Event
Injury
·AMBU A/S·Product code BTO·July 10, 2025
AURAGAIN
FDA Adverse Event
Injury
·AMBU A/S·Product code CAE·July 10, 2025
Lap-Band Access Port Needle 10-Pack, 20 G x 51 mm (2 in.), Product Code: 8-20302-10, Lot Number: 9L01N 20 gauge, 51 mm (2 in.) length non-coring deflected tip (Huber) needle, used with the LAP-BAND System for band adjustment.
FDA Recall
Terminated
·Allergan·Product code LTI·March 21, 2011