18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Accessory Irrigation Adapter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Evolve
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215002220·
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·October 18, 2002
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138647·Broach, 42 X 32, 13mm Height 17° Hyperlordotic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138661·Broach, 42 X 32, 17mm Height 17° Hyperlordotic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138685·Broach, 42 X 32, 21mm Height 17° Hyperlordotic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138654·Broach, 42 X 32, 15mm Height 17° Hyperlordotic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138678·Broach, 42 X 32, 19mm Height 17° Hyperlordotic
GLOOKO LOGBOOK CHARTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161111621420·Cemented Stem, High Offset, Size 1
STAPLE, IMPLANTABLE
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 19, 2017
SPECTRA OPTIA
FDA Adverse Event
Injury
·TERUMO BCT·Product code LKN·December 23, 2024
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·October 10, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 3, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
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