11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEXXT MATRIXX Stand Alone Cervical System
FDA 510(k)
FDA Class 2
·Orthopedic
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017934·K-Wire, Double Ended, Trocar Point, Diameter Si...
Pre-Finisher
FDA UDI
TP ORTHODONTICS INC·00192029042274·4 Bicuspid Extraction w/Seating Springs
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306804700·Castroviejo Caliper Graduated 0-20mm, 8.5cm
PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
MODIFICATION TO NORDICICE SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
BAERVELDT SHUNT
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYF·September 15, 2020
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·October 2, 2008
CONTINUOUS NERVE BLOCK KIT
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code CAZ·June 21, 2013
EASYTRAK 2
FDA Adverse Event
Injury
·GUIDANT PUERTO RICO BV·Product code OJX·August 4, 2011
Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF: 1005611; Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement, REF: 1005613; Pump, t:slim X2, Control-IQ, mg/dl, REF: 1005615; Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement, REF: 1005617; Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement, REF: 1006379; Pump, t:slim X2, Control-IQ 7.4, REF: 1006402; Pump, t:slim X2, Control-IQ 7.4, Replacement, REF: 1006406; Pump, t:slim X2, Control-IQ 7.4, REF: 1006408; Pump, t:slim X2, Basal-IQ, , REF: 1006419; Pump, t:slim X2, Basal-IQ, mg/dL, REF: 1006420; Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement, REF: 1006535; Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement, REF: 1006537; Pump, t:slim X2, Control-IQ, mg/dl , Replacement, REF: 1008255; Pump, t:slim X2, Control-IQ, mmoUL, Replacement, REF: 1008256; Pump, t:slim X2, Basal-IQ, mmoUL, Replacement, REF: 1008257; Pump, t:slim X2, Basal-IQ, mg/dl ,Replacement, REF: 1008258; Pump, t:slim X2, Basal-IQ, REF: 1010004; Pump, t:slim X2, Basal-IQ, Replacement, REF: 1010005; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010006; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010007; Pump, t:slim X2, Control-IQ, REF: 1010009; Pump, t:slim X2, Control-IQ Replacement, REF: 1010010; Pump, t:slim X2, Control-IQ, Medicare, REF: 1010011; Pump, t:slim X2, Control-IQ, Refurbished Replacement, REF: 1010012; Pump, t:slim X2, Control-IQ, REF: 1012867; Pump, t:slim X2, Control-IQ, Medicare, REF: 1012868; Pump, t:slim X2, Control-IQ, Replacement, REF: 1012869; Pump, t:slim X2, Control-IQ 7.8, REF: 1013195; Pump, t:slim X2, Control-IQ 7.8, Medicare, REF: 1013196; Pump, t :slim X2, Control-IQ 7.8, Replacement, REF: 1013197; Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement, REF: 1013198
FDA Enforcement
Class I
·Ongoing·Tandem Diabetes Care, Inc.·September 3, 2025