9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Skypro, SP01 Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Trial Cups
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215038885·
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·October 31, 2019
FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MEMOMETAL INTRA-MEDULLARY BONE FASTENER
FDA 510(k)
FDA Class 2
·Orthopedic
IDENTITY ADX SR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DXY·January 13, 2014
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code OJX·June 7, 2013
AVS PL SPACER 7 X 25 X 4 DEG - 8
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MAX·June 23, 2011
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023