10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SWIMEX MULTIDEPTH POOL (MODEL 600T)
FDA 510(k)
FDA Class 1
·Physical Medicine
OMNI Knee
FDA UDI
Omni Life Science, Inc.·00841690101161·Congruent Tibial Insert, Size 1 x 11mm
Cranial Fusion
FDA UDI
Life Spine, Inc.·00190837085292·
ELMED
FDA UDI
ELMED INCORPORATED·00842180159419·Brooks Style” non-sterile, reusable, medical-gr...
ORAL PHARYNGEAL CLEANSING DEVICE
FDA 510(k)
FDA Class 1
·Dental
NEBULIZER PUMP, POWERED MODEL 1180
FDA 510(k)
FDA Class 2
·Anesthesiology
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·December 21, 2010
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 14, 2013
SYNERGY VERSITREL
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 15, 2014
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022