19 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Anzai Respiratory Gating System
FDA 510(k)
FDA Class 2
·Radiology
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ORIGIN ZIRCONIA
FDA 510(k)
FDA Class 2
·Dental
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·March 31, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·June 11, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·May 30, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·March 5, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·June 5, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·January 28, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·July 28, 2025
DXTEND STAND PE CUP D38 +6MM
FDA Adverse Event
Injury
·3003895575 DEPUY FRANCE S.A.S.-SAINT PRIEST·Product code KWS·June 14, 2013
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 23, 2011
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008
ENDOWRIST
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·October 6, 2022
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·September 30, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·May 12, 2025
CRE PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KTI·January 10, 2025
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022
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