21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Biosens cartridges Opaque Pink
FDA UDI
PERFLEX LTD·07290110501631·box of 6 identical cartridges sealed in a vacuu...
T-Crystal cartridges Opaque Pink
FDA UDI
PERFLEX LTD·07290110500238·Box of 6 identical cartridges sealed in aluminu...
Driver
FDA UDI
ELLIQUENCE, LLC·00846338002169·
TLIF/PLIF Disc Prep
FDA UDI
Life Spine, Inc.·00190837086947·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450835777·
T-Crystal cartridges Opaque Pink
FDA UDI
PERFLEX LTD·07290110506131·5 identical cartridges sealed in a vacuum bag ;...
S9 VPAP ST WITH H5I
FDA 510(k)
FDA Class 2
·Anesthesiology
LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PENCAN®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code BSP·May 6, 2025
DELTA CER HEAD 11/13 32MM +6
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code LZO·August 5, 2014
DELTA CER INSERT 36ID X 62OD
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code MRA·August 5, 2014
DELTA CER HEAD 11/13 36MM +9
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code LZO·August 5, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·May 14, 2013
LD304 MATERNITY BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code HDD·May 25, 2011
TRUWAVE DISPOSABLE PRESSURE TRANSDUCERW/VAMP COMBO
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DRS·August 8, 2008
PENCAN®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code BSP·April 10, 2025
WALLFLEX? BILIARY TRANSHEPATIC
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·August 21, 2012
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
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