7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SECRET RF
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CLEARFIL MAJESTY ESTHETIC PLT
FDA 510(k)
FDA Class 2
·Dental
PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES
FDA 510(k)
FDA Class 2
·Orthopedic
2124215-2011-09860
FDA Adverse Event
Injury
·GUIDANT PUERTO RICO BV·Product code NVN·July 20, 2011
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 28, 2013
LIFEPAK CR PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·September 12, 2008
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024