31 results
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47ms
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Sources: EU EUDAMED, US FDA
SHEEHY-HOUSE POWDER INSUFFLATOR
FDA UDI
Oto-Med, Inc.·00850000126053·SHEEHY-HOUSE POWDER INSUFFLATOR
LEVINE IRRIGATION-SUCTION TUBING
FDA UDI
Oto-Med, Inc.·00850000126152·LEVINE IRRIGATION-SUCTION TUBING
OTOMED® SUCTION TUBING
FDA UDI
Oto-Med, Inc.·00850000126121·OTOMED® SUCTION TUBING
LEVINE IRRIGATION-SUCTION KIT
FDA UDI
Oto-Med, Inc.·00850000126114·LEVINE IRRIGATION-SUCTION KIT
CI UNIVERSAL DRAPE
FDA UDI
Oto-Med, Inc.·00850000126169·CI UNIVERSAL DRAPE
EAR DRESSING, ADULT
FDA UDI
Oto-Med, Inc.·00850000126138·EAR DRESSING, ADULT
COX BONE DUST COLLECTOR
FDA UDI
Oto-Med, Inc.·00850000126060·COX BONE DUST COLLECTOR
HEAD & NECK PRESSURE DRESSING
FDA UDI
Oto-Med, Inc.·00850000126039·HEAD & NECK PRESSURE DRESSING
GLASSCOCK NEUROTOLOGY SURGERY DRAPE
FDA UDI
Oto-Med, Inc.·00850000126091·GLASSCOCK NEUROTOLOGY SURGERY DRAPE
GLASSCOCK® EAR DRESSING, ADULT
FDA UDI
Oto-Med, Inc.·00850000126015·GLASSCOCK® EAR DRESSING, ADULT
GLASSCOCK OTOLOGY SURGERY DRAPE
FDA UDI
Oto-Med, Inc.·00850000126084·GLASSCOCK OTOLOGY SURGERY DRAPE
GLASSCOCK® EAR DRESSING, PEDIATRIC
FDA UDI
Oto-Med, Inc.·00850000126022·GLASSCOCK® EAR DRESSING, PEDIATRIC
SAFETRAP TISSUE COLLECTOR
FDA UDI
Oto-Med, Inc.·00850000126107·SAFETRAP TISSUE COLLECTOR
EAR DRESSING, PEDIATRIC
FDA UDI
Oto-Med, Inc.·00850000126145·EAR DRESSING, PEDIATRIC
SHEEHY BONE DUST COLLECTOR
FDA UDI
Oto-Med, Inc.·00850000126046·SHEEHY BONE DUST COLLECTOR
spineX BONE DUST COLLECTOR
FDA UDI
Oto-Med, Inc.·00850000126077·spineX BONE DUST COLLECTOR
Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Enforcement
Class II
·Ongoing·Oto Med Inc·May 12, 2021
Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Enforcement
Class II
·Ongoing·Oto Med Inc·May 12, 2021
Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Enforcement
Class II
·Ongoing·Oto Med Inc·May 12, 2021
Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Recall
Open, Classified
·Oto Med Inc·Product code MXP·December 7, 2020