17 results · 23ms · Sources: EU EUDAMED, US FDA

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Gems Oocyte Retrieval Buffer ORB-20, ORB-50

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY

FDA 510(k)
FDA Class 2 ·Orthopedic

HYPER SAL

FDA 510(k)
FDA Class 2 ·Anesthesiology

LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code DRB·January 8, 2021

URETEX SUPPORT PP KIT X1

FDA Adverse Event
Injury ·SOFRADIM PRODUCTION·Product code OTN·June 12, 2013

ACCU-CHEK ® MOBILE COMPACT STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 21, 2011

ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code MCX·October 14, 2014

LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code DQX·August 14, 2024

LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

FDA Adverse Event
Death ·COOK VANDERGRIFT INC·Product code DRB·August 23, 2024

LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code DQX·August 23, 2024

LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code DRB·February 12, 2024

LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code DRB·March 13, 2024

LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code DQX·November 8, 2024

LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code DRB·February 12, 2024

LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code DQX·October 25, 2024

LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

FDA Adverse Event
Injury ·COOK VASCULAR INC·Product code DRB·September 14, 2018

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