4 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Endovascular Pack, code 900-2715, contains: ( I) DRAPE FEMORAL ANG. 125 X 75 X 56 WITH POUCH LIF (2) TOWELS ABSORBENT 15 X 20 LIF ( I) CONTAINER SPECIMEN 4oz W/LID & LABEL Llf (2) BAG BAND FLUOROSCOPE 36 X 30 LIF ( I) NEEDLE HYPODERMIC 21G X I Y, LIF (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI III LIF (2) SOLUTION SURGICAL DURAPREP 6ML LIF ( I) BAG BAND RUB BAND & TAPE 42 X 38 LIF (4) TOWELS CLOTH HUCK BLUE LIF (I) Pr. GLOVE SYNTEGRA CR 6.5 POWDER FREE Llf (2) Pr. GLOVE SYNTEGRA CR 8 POWDER FREE LIF ( I) NEEDLE HYPODERMIC 25G X 5/8 LIF ( I) SYRINGE 30CC WITHOUT NEEDLE LUER LOCK LIF (I) COYER TABLE 44 X 90 LIF ( I) SCALPEL WITH HANDLE (25) GAUZE SPONGES 4 X 4 12PLY LIF (2) CLAMP TOWEL (2) SYRINGE I OCC WITHOUT NEEDLE LUER LOCK LIF ( I) NEEDLE HYPODERMIC 18G X I Y, LIF ( I) SHARP STOP NEEDLE HOLDER LIF ( I) TRAY ORGANIZER FULL DEEP ( I) NEEDLE 18G X 23 (I) BOWL UTILITY BLUE 16oz LIF ( I) WRAPPER 24X 24 LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
Endo-Model Replacement Plateau; Item Number: 15-0027/15;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018