13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Photonica Professional
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699588·GENUMEDI PSS BLUE, SIZE VI
Oticon
FDA UDI
Oticon A/S·05707131286819·H10V2, MINIRITE 312 WL CNB
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306820090·Marina Dissector, 4mm Mini-Cottle Finishing Tip...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197399531·Tebbet Breast Retractor
150x36...
T:FLEX INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·May 5, 2021
MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711
FDA 510(k)
FDA Class 2
·Microbiology
OPD-STATION SOFTWARE
FDA 510(k)
FDA Class 1
·Ophthalmic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 25, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·October 7, 2014
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·May 30, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024