10 results
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6ms
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Sources: EU EUDAMED, US FDA
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714729960904
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·January 20, 2021
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 08714729960911, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·January 20, 2021
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVSUS270, GTIN 08714729960928, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·January 20, 2021
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 08714729940838, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·January 20, 2021
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 08714729940821, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·January 20, 2021
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVS230, GTIN 08714729940814, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·January 20, 2021
Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are packaged in a Tyvek pouch and then placed inside a cardboard box. 15 filters per box The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose
FDA Enforcement
Class I
·Terminated·Nephros Inc·December 25, 2013
1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose
FDA Enforcement
Class I
·Terminated·Nephros Inc·December 25, 2013
OPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) OPHTALMIC DRAPE WITH POUCH LIF (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (10) COTTON TIP APPLICATOR 6" WOOD (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC 18G X 1 Y." (1) NEEDLE HYPODERMIC 25G X 5/8" (2) EYE PAD 2 1/8 X 2 5/8 UF (5) EYE SPEAR MICRO SPONGE (2) LITE GLOVE LIF (1) CABLE BIPOLAR (1) EYE SHIELD UNIVERSAL (1) OPHTALMIC PENCIL BIPOLAR (1) IV ADM. SET 15 DROPS 106" LONG L/F (1) TABLE COVER REINFORCED 50" X 90" UF (1) KNIFE/BLADE MIN. EDGE ROUND (1) KNIFE 15 5.0 CONTROLLED (1) PLASTIC TRAY 3/COMPARTMENT (1)KNIFE 3.2MM ANGLE BEVEL UP (1) CYSTOTOMO IRRIG. 25GA X5/8 (1) MAYO TRAY LARGE (2) GOWN STANDARD LARGE SMS STD VELCRO NECK (1) PVP PAINT 8" STICK SPONGE (1) NEEDLE & BLADE COUNTER 30c MAG/MAG/LF 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
Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description Material Number (UPN) Guiding Sheath 5F, 45 cm, ST, CC H74939277545110 Guiding Sheath 5F, 45 cm, MP, CC H74939277545210 Guiding Sheath 6F, 45 cm, ST, CC H74939277645110 Guiding Sheath 6F, 45 cm, ST, TB H74939277645120 Guiding Sheath 6F, 45 cm, MP, CC H74939277645210 Guiding Sheath 6F, 45 cm, MP, TB H74939277645220 Guiding Sheath 6F, 65 cm, ST, CC H74939277665110 Guiding Sheath 6F, 65 cm, ST, TB H74939277665120 Guiding Sheath 6F, 90 cm, ST, CC H74939277690110 Guiding Sheath 6F, 90 cm, ST, TB H74939277690120 Guiding Sheath 6F, 90 cm, MP, CC H74939277690210 Guiding Sheath 6F, 90 cm, MP, TB H74939277690220 Guiding Sheath 7F, 45 cm, ST, CC H74939277745110 Guiding Sheath 7F, 45 cm, ST, TB H74939277745120 Guiding Sheath 7F, 45 cm, MP, CC H74939277745210 Guiding Sheath 7F, 45 cm, MP, TB H74939277745220 Guiding Sheath 7F, 65 cm, ST, CC H74939277765110 Guiding Sheath 7F, 65 cm, ST, TB H74939277765120 Guiding Sheath 7F, 90 cm, ST, CC H74939277790110 Guiding Sheath 7F, 90 cm, ST, TB H74939277790120 Guiding Sheath 7F, 90 cm, MP, CC H74939277790210 Guiding Sheath 7F, 90 cm, MP, TB H74939277790220 Guiding Sheath 8F, 45 cm, ST, CC H74939277845110 Guiding Sheath 8F, 45 cm, ST, TB H74939277845120 Guiding Sheath 8F, 45 cm, MP, CC H74939277845210 Guiding Sheath 8F, 65 cm, ST, CC H74939277865110 Guiding Sheath 8F, 65 cm, ST, TB H74939277865120 Guiding Sheath 8F, 90 cm, ST, CC H74939277890110 Guiding Sheath 8F, 90 cm, ST, TB H74939277890120 Product Usage: The Chariot Guiding Sheath is designed to perform as an introducer sheath for delivering interventional and diagnostic devices into the peripheral vasculature. The guiding sheath has a coiled shaft design and comes with a straight or preformed multipurpose tip shape. It is equipped with a cross-cut hemostatic valve or Tuohy-Borst adapter to prevent bleeding and a sidearm with a three-way stopcock to allow for flushing and introduction of contrast medium. It is packaged with a dilator to facilitate delivery over a guidewire. The guiding sheath can accommodate guidewires with diameters less than or equal to 0.038 in (0.97 mm). The outer surface of the guiding sheath has a hydrophilic coating from the distal tip to approximately 9 cm from the hub. The distal tip has a radiopaque marker band approximately 6 mm from the distal edge, to help with guiding sheath placement.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·December 30, 2015