BEUDAMED
    279 results · 21ms · Sources: EU EUDAMED, US FDA

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    Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation.

    FDA Recall
    Terminated ·Teleflex Medical·Product code GAT·March 11, 2014

    QuickGraft Model # 430PST

    FDA Recall
    Terminated ·Musculoskeletal Transplant Foundation, Inc.·Product code GAT·August 15, 2019

    OPUS SpeedStitch Product Number OM-8086 is a suture cartridge For use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code GAT·August 8, 2011

    Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; Tevdek II, Green Braided PTFE Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP Sterile, Deknatel; Tevdek II, White Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP, Sterile, Deknatel; Silky II Polydek White Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable surgical Suture, USP, Sterile, Deknatel; Silky II Polydek, Green Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP, Sterile, Deknatel; Polylene Green Braided Polyester Suture Nonabsorbable surgical Suture, USP, Deknatel; Bard FIXT Braided Polyester, Green PTFE Rx Only, Teleflex Research Triangle Park, NC USA, Assembled in Mexico. Indicated for use in soft tissue approximation.

    FDA Recall
    Terminated ·Teleflex Medical·Product code GAT·March 11, 2014

    Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971

    FDA Recall
    Terminated ·ArthroCare Corporation·Product code GAT·February 21, 2019

    Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage: Non-absorbable poly(ethylene terephthalate) surgical suture is a multifilament, non-absorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation.

    FDA Recall
    Terminated ·Teleflex Medical·Product code GAT·March 11, 2014

    The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOXYL sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for double armed (36 sutures), 24 units for ligatures (24 reels), 12 packs for double armed (5 Green/5 White) (120 sutures).

    FDA Recall
    Terminated ·Peters Surgical 42 Rue Benoit Frachon Bobigny France·Product code GAT·June 25, 2014

    Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product Usage: Non-absorbable polyamide surgical suture is a non-absorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation.

    FDA Recall
    Terminated ·Teleflex Medical·Product code GAT·March 11, 2014

    Brand name: Stylus 2-0 Polyviolene Double Armed with T Taper needles. Common name: 20- Polyviolene (white braided coated polyester) with T Taper needles (double armed)

    FDA Recall
    Terminated ·Surgical Specialties Corp·Product code GAT·August 25, 2003

    Smith & Nephew FAST FIX 360, REVERSE CURVED NEEDLE Catalog Number; 72202469. Intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair, and gastrostomy.

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code GAT·October 14, 2010

    Smith & Nephew FAST FIX 360, CURVED NEEDLE Catalog Number; 72202468. Intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair, and gastrostomy.

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code GAT·October 14, 2010

    Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation.

    FDA Recall
    Terminated ·Teleflex Medical·Product code GAT·March 11, 2014

    Product is an EO Sterile, Polyester braided and coated nonabsorbable surgical suture with double needle, size 2/0 (3.0 Metric), NSH 26 mm TAPER Needle. Product is wrapped in a five-fold card with inserted flap ends (overwrap). A label is placed on the overwrap and the packet is then inserted into a tyvek/mylar pouch. One end of the overwrap card is printed with 'Open'. This end is positioned in the pouch so it is closest to the peel-open end. No suture is exposed or visible through the overwrap which must be torn to have access to the suture and needle. Product is boxed (12 to a box) and shrink wrapped. Product overwrap label includes: '2/0 (3.0 metric) CP523A Polybond Green Braided, Polyester Coated Nonabsorbable Sterile Suture Rx Only TAPER NSH 36' (90cm) 1/2 26mm Manufactured by CP Medical Portland, OR USA'. Product box label includes: '2/0 (3.0 metric) CP523A NSH 26 mm 1/2 TAPER POLYBOND Green Polyester Braided Coated Nonabsorbable 36' (90cm) STERILE EO Manufacturer CP Medical Portland, OR USA' . Product was distributed to single consignee, a distributor in South Africa.

    FDA Recall
    Terminated ·C P Medical·Product code GAT·April 3, 2007

    Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico. Indicated for use in soft tissue approximation.

    FDA Recall
    Terminated ·Teleflex Medical·Product code GAT·March 11, 2014

    The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated, with or without PLEDGETS of different sizes. CARDIOFLON Evolution sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOFLON Evolution sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures, except for some diameters. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for single or double armed (36 sutures), 24 units of ligatures (24 reels), 12 packs for double armed (10 Green or 5 Green/5 White) (120 sutures).

    FDA Recall
    Terminated ·Peters Surgical 42 Rue Benoit Frachon Bobigny France·Product code GAT·June 25, 2014

    Smith & Nephew FAST FIX 360, STRAIGHT NEEDLE Catalog Number; 72202467. Intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair, and gastrostomy.

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code GAT·October 14, 2010

    Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or Ushaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

    FDA Recall
    Terminated ·Teleflex Medical·Product code GAT·March 11, 2014

    Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural non-absorbable silk surgical suture is indicated for use in soft tissue approximation. Natural non-absorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Non-absorbable Surgical Suture (class I). Natural non-absorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.

    FDA Recall
    Terminated ·Teleflex Medical·Product code GAT·March 11, 2014

    ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code GAT·April 30, 2015

    Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 9108494 ATF 40 Fast Start Kits); 2. AT-3 Autotransfusion sets and kits (Part 9005444 AT-3 set, 9104444 ATF-120 Fast Start Kits (AT-3), or 9108444 ATF-40 Fast Start Kits AT-3) Product Usage: The Fresenius Kabi CATSmart device (Continuous auto transfusion System) is indicated for the processing of autologous shed blood collected interaoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. The CATSmart Auto transfusion System is designed to reduce the need for allogeneic blood transfusion by re-infusing a patient s own lost blood during surgery. The set is used as a disposable component of the autotransfusion system during surgery and/or treatment of trauma to remove waste and improve the safety of autologous re-infused blood (auto transfusion). This is a single-use device.

    FDA Enforcement
    Class II ·Terminated·Fenwal Inc·May 1, 2019