17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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