4 results
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15ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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GE Healthcare Discovery IQ X-ray system
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 21, 2017
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·July 20, 2016
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·July 20, 2016
LAMINECTOMY PACK - ( I) RING BASIN LIF (2) TABLE COVER REINFORCED 50" X 90" LIF ( I) SKIN MARKER INK W/8 LABEL ( I) CAUTERY TIP POLISHER LIF ( I) TUBE SUCTION CONNECT. W' X 12' LIF (6) DRAPE UTILITY W/TAPE LIF (I 0) GAUZE SPONGE 4" X 4" 16PL Y LIF (2) UTILITY BOWL 16oz. LIF ( IO) LAP SPONGE PRE-WASH XRD LIF (2) SPECIMEN CONTAINER 4oz W/LID & LABEL (2) MAYO STAND COVER REINFORCED LIF ( I) GOWN SURG. REINF. XL TOWEL WRAP (6) ABSORBENT TOWEL I5" X 20" LIF ( I) DRAPE LAP 102" X 121" X 78" W/POUCI-1 SMS LIF ( I) SURGICAL DURAPREP SOLUTION 26ML LIF (6) DRAPE SHEET 41" X 69" MEDIUM LIF (2) LEGGING W/7'' CUFF 30" X 42" LIF (2) NEEDLE & BLADE COUNTER I Oc MAG /CLEAR ( I) CAUTERY PENCIL PUSH BOTTOM LIF ( I) BAG SUTURE FLORAL LIF ( I) PVP SCRUB 8" STICK SPONGE ( I) MAYO TRAY LARGE LIF (I 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF ( I) SURGICAL BLADE# I 0 CARBON STEEL (2) BULB SYRINGE 60cc CLEAR LIF ( I) SURGICAL BLADE# I I CARBON STEEL ( I) SURGICAL BLADE # 15 CARBON STEEL ( I) GOWN FABRIC REINFORCED SONTARA XL LIF ( I) SYRINGE IOcc W/NDL 20G X I Y, LILOCK LIF ( I) PVP PAINT 8" STICK SPONGE ( I) SURGICAL STRIP W' X 6" COTTON (2) LITE GLOVES LIF 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