BEUDAMED
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    Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Thru Intraluminal Shunt, Item Numbers: a) FT12100, b) FT12125, c) FT12150, d) FT12175, e) FT12200, f) FT12225, g) FT12250, h) FT12275, i) FT12300,

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·April 24, 2024

    Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Vascular Probe, Item Numbers: a) 7081015, b) 7081015ES, c) 7081520, d) 7081520ES, e) 7082025, f) 7082025ES, g) 7151015, h) 7151015ES, i) 7151520, j) 7151520ES, k) 7152025, l) 7152025ES, m) 7451015, n) 7451015ES, o) 7451520, p) 7451520ES, q) 7452025, r) 7452025ES

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·April 24, 2024

    Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Rester Disposable Internal Vessel Occluder, Item Numbers: a) 50100, b) 50125, c) 50150, d) 50175, e) 50200, f) 50225, g) 50250, h) 50275, i) 50300, j) 50350, k) 50400, l) 50450BIOS, m) 60100, n) 60125BIOS, o) 60150BIOS, p) 60175, q) 60200BIOS, r) 60225BIOS, s) 60250BIOS, t) 60275, u) 60300, v) 60350, w) 60400BIOS, x) 60450BIOS

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·April 24, 2024

    MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.

    FDA Enforcement
    Class II ·Terminated·Kimberly-Clark Corporation·July 25, 2012

    POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N

    FDA Enforcement
    Class II ·Ongoing·SURGICAL SPECIALTIES·April 24, 2024

    BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.

    FDA Enforcement
    Class II ·Terminated·Surgical Specialties Mexico S DE RL DE CV·October 19, 2016

    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***" Ophthalmic surgery

    FDA Enforcement
    Class II ·Terminated·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.·November 14, 2012

    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3240***" Ophthalmic surgery

    FDA Enforcement
    Class II ·Terminated·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.·November 14, 2012

    Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N

    FDA Enforcement
    Class II ·Terminated·SSC- Surgical Specialties Corporation·June 29, 2016

    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***" Ophthalmic surgery

    FDA Enforcement
    Class II ·Terminated·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.·November 14, 2012

    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***" Ophthalmic surgery

    FDA Enforcement
    Class II ·Terminated·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.·November 14, 2012

    Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS

    FDA Enforcement
    Class II ·Ongoing·Carefree Surgical Specialties·August 20, 2025

    Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS

    FDA Enforcement
    Class II ·Ongoing·Carefree Surgical Specialties·August 20, 2025

    Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15506/25 Product Description: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes

    FDA Enforcement
    Class II ·Ongoing·Carefree Surgical Specialties·August 20, 2025

    Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15508/25 Product Description: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes

    FDA Enforcement
    Class II ·Ongoing·Carefree Surgical Specialties·August 20, 2025

    bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

    Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

    FDA Enforcement
    Class II ·Ongoing·Covidien Llc·June 10, 2020

    Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

    FDA Enforcement
    Class II ·Ongoing·Covidien Llc·June 10, 2020

    Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

    FDA Enforcement
    Class II ·Ongoing·Covidien Llc·June 10, 2020

    Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

    FDA Enforcement
    Class II ·Ongoing·Covidien Llc·June 10, 2020