BEUDAMED
    36 results · 12ms · Sources: EU EUDAMED, US FDA

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    Product's marketing brochure is labeled in part: "Philips Easy Diagnost Eleva Conventional R/F system...PHILIPS". manufactured by Philips Medical Systems Gmbh, Hamburg, Germany.

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code KPR·January 21, 2009

    ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories·July 4, 2012

    ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code NIG·May 30, 2012

    Opti-Plast Balloon Dilatation Catheters

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code GBR·August 20, 2003

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-4515

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-5020

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-7020

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/2.0 cm/150 cm, Reference Catalog Number 38950-5020

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/2.0 cm/150 cm, Reference Catalog Number 38950-6020

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-4020

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.5 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-5520

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part number: GP8665 Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.

    FDA Recall
    Terminated ·Riverpoint Medical, LLC·Product code GAR·August 5, 2016

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/ 2.0 cm/90 cm, Reference Catalog Number 37915-5020

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/ 1.5 cm/90 cm, Reference Catalog Number 37915-6015

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    Look Brand Black Monofilament Nylon Suture. 2xS Taper Straight 61 mm 2/0 Black Monofilament Nylon 30''. Model number 933B. The product is shipped in boxes containing 12 units.

    FDA Recall
    Terminated ·Surgical Specialties Corp·Product code GAR·September 24, 2005

    Monomid Non-Absorbable Suture are blue, monofilament synthetic absorbable suture, with different sizes and different needle sizes. The products are labeled in parts. These sutures are intended for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, and neurological surgery.

    FDA Recall
    Terminated ·C P Medical Inc.·Product code GAR·June 29, 2011

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-4020

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-4520

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.

    FDA Recall
    Terminated ·Surgical Specialties Corp·Product code GAR·September 9, 2008

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 1.5 cm/90 cm, Reference Catalog Number 37915-4515

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003