15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NeoLSD MSMS kit
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306821219·Forceps, Bishop-Harmon, 0.8mm Tip, 9cm
ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE
FDA 510(k)
FDA Class 2
·Orthopedic
KNEEALIGN SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
SYRINGE 10ML SALINE FILL CHINA SP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code NGT·February 22, 2024
18G X 1.16IN (1.3 X 30 MM) ANGIOCATH
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·November 21, 2019
ALTRUA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 24, 2011
ACT 5DIFF RINSE
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JCB·June 17, 2013
ROTATABLE SNARE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FDI·October 15, 2014
BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQO·January 18, 2019
BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code DQO·November 26, 2019
BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code DQO·November 26, 2025
BD ANGIOCATH¿ IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·June 1, 2018
Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
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