10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD BBL™ Sensi-Disc™ Carbenicillin - 100 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902315552·BD BBL™ Sensi-Disc™ Carbenicillin - 100 µg
MEDSOURCE IV SAFETY CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 17, 2014
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 22, 2011
SECURE 3 MED/SURG BEDOBS 01/13
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 17, 2013
RESTORE ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 15, 2014
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
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