2 results · 22ms · Sources: EU EUDAMED, US FDA

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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

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-25 b. ACUMATCH GXL 0 DEGREE LINER 28MM SZ F, REF 130-28-26 c. ACUMATCH GXL 0 DEGREE LINER 28MM SZ G, REF 130-28-27 d. ACUMATCH GXL 0 DEGREE LINER 28MM SZ H, REF 130-28-28 e. ACUMATCH GXL 0 DEGREE LINER 28MM SZ J, REF 130-28-29 f. ACUMATCH GXL 0 DEGREE LINER 32MM SZ G, REF 130-32-27 g. ACUMATCH GXL 0 DEGREE LINER 32MM SZ H, REF 130-32-28 f. ACUMATCH GXL 0 DEGREE LINER 32MM SZ J, REF 130-32-29 g. ACUMATCH GXL 0 DEGREE LINER 36MM SZ H, REF 130-36-28 h. ACUMATCH GXL 0 DEGREE LINER 36MM SZ J, REF 130-36-29 i. ACUMATCH GXL 0 DEGREE LINER 36MM SZ K, REF 130-36-30 j. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ E, REF 138-28-25 k. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ F, REF 138-28-26 l. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ G, REF 138-28-27 m. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ H, REF 138-28-28 n. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ J, REF 138-28-29 o. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ H, REF 138-36-28 p. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ J, REF 138-36-29 q. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ K, REF 138-36-30 r. ACUMATCH GXL 15 DEG +5 LAT LINER SZG 38MM, REF 138-36-27 s. ACUMATCH GXL 15DEG LINER 28MM SZ D, REF 132-28-24 t. ACUMATCH GXL 15DEG LINER 28MM SZ E, REF 132-28-25 u. ACUMATCH GXL 15DEG LINER 28MM SZ F, REF 132-28-26 v. ACUMATCH GXL 15DEG LINER 28MM SZ G, REF 132-28-27 w. ACUMATCH GXL 15DEG LINER 28MM SZ H, REF 132-28-28 x. ACUMATCH GXL 15DEG LINER 28MM SZ J, REF 132-28-29 y. ACUMATCH GXL 15DEG LINER 28MM SZ K, REF 132-28-30 z. ACUMATCH GXL 15DEG LINER 32MM SZ G, REF 132-32-27 aa. ACUMATCH GXL 15DEG LINER 32MM SZ H, REF 132-32-28 bb. ACUMATCH GXL 15DEG LINER 32MM SZ J, REF 132-32-29 cc. ACUMATCH GXL 15DEG LINER 32MM SZ K, REF 132-32-30 dd.ACUMATCH GXL 15DEG LINER 36MM SZ H, REF 132-36-28 ee. ACUMATCH GXL 15DEG LINER 36MM SZ J, REF 132-36-29 ff. ACUMATCH GXL 15DEG LINER 36MM SZ K, REF 132-36-30 gg. ACUMATCH GXL EXT COV LINER 28MM SZ E, REF 134-28-25 hh. ACUMATCH GXL EXT COV LINER 28MM SZ F, REF 134-28-26 ii. ACUMATCH GXL EXT COV LINER 28MM SZ G, REF 134-28-27 jj. ACUMATCH GXL EXT COV LINER 28MM SZ H, REF 134-28-28 kk. ACUMATCH GXL EXT COV LINER 28MM SZ J, REF 134-28-29 ll. ACUMATCH GXL EXT COV LINER 28MM SZ K, REF 134-28-30 mm. MCS GXL LINER 5/15 DEG 4448X28, REF 104-28-43 nn. MCS GXL LINER 5/15 DEG 5052X28, REF 104-28-44 oo. MCS GXL LINER 5/15 DEG 5458X28, REF 104-28-45 pp. MCS GXL LINER 5/15 DEG 5458X32, REF 104-32-45 qq. MCS GXL LINER 5/15 DEG 6064X32, REF 104-32-46 rr. MCS GXL LINER 5/15 DEG 6064X36, REF 104-36-46 ss. MCS GXL LINER 5/15 DEG 6670X36, REF 104-36-47

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022