BEUDAMED
    89 results · 7ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii × Status: Terminated × Clear all

    EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, and 3cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile). A temporary sensing electrode feature may be used with an off-the-shelf electrogram recording system with the use of an additional instrument cable (non-sterile). An accessory Cannula may be used to facilitate coagulation device access and visibility of the heart. The EPi-Sense Guided Coagulation System with VisiTrax technology is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques and may be used for temporary cardiac signal sensing and recording during surgery when connected to a temporary external recording device.

    FDA Enforcement
    Class II ·Terminated·AtriCure, Inc.·July 3, 2019

    CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile needle guides (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 22 GAUGE, Rx.

    FDA Enforcement
    Class II ·Terminated·CIVCO Medical Instruments Co., Inc.·December 19, 2018

    CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 21 GAUGE, Rx.

    FDA Enforcement
    Class II ·Terminated·CIVCO Medical Instruments Co., Inc.·December 19, 2018

    CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 22 GAUGE, Rx.

    FDA Enforcement
    Class II ·Terminated·CIVCO Medical Instruments Co., Inc.·December 19, 2018

    CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 21 GAUGE, Rx. The firm name on the label is CIVCO, Kalona, IA..

    FDA Enforcement
    Class II ·Terminated·CIVCO Medical Instruments Co., Inc.·December 19, 2018

    Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N, 1 cm x 10 cm, product code VG0110N, and 2 cm x 9 cm, product code VG0209N. VASC U-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Sterilized using aseptic processing techniques. The pericardium is procured from cattle originating in the United States. VASC-Guard is chemically sterilized using ethanol and propylene oxide. UPDATE 9/1/2016 Retrieval of devices only includes Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·August 24, 2016

    2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. ENT Precision Cutter, Aggressive, ESSxlHUMMER 4, Rx Only It is used for ENT procedures and functions by means of rotation when adapted to a handpiece and console. Through the rotation, the necessary tissue is resected as required by the user. The blade housing has an etching line guide that starts with a straight line and along with a scale from 1cm to 7cm in 1cm increments that serves the doctor as a guide by indicating how far the device is being introduced into the surgical area.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·March 26, 2014

    Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM, MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM, MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM, MCA5-1SB - lMM FLUTED BALL, 5.6CM, MCA5-1SD - lMM DIAMOND BALL, 5.6CM, MCA5-2SB - 2MM FLUTED BALL, 5.6CM, MCA5-2SD - 2MM DIAMOND BALL, 5.6CM, MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM, MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM, MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM, MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM, MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM, MCA7-15SD  1.5MM DIAMOND BALL, 7.3CM, MCA7-1SB - lMM FLUTED BALL, 7.3CM, MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM, MCA7-2SB - 2MM FLUTED BALL, 7.3CM and MCA7-2SD - 2MM DIAMOND BALL, 7.3CM. The MCA attachment is a reusable device used with dissection tools. Dissection tools are single use, disposable cutter designed for cutting and shaping delicate bone, primary in otology procedures for delicate bone cutting.

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·January 15, 2014

    progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM3004, 4 x 4 cm; PM3006, 6 x 6 cm; and PM3010, 10 x 10 cm.

    FDA Enforcement
    Class II ·Terminated·ProgenaCare·June 1, 2022

    PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.

    FDA Enforcement
    Class II ·Terminated·TEI Biosciences·January 24, 2018

    GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).

    FDA Enforcement
    Class II ·Terminated·Codman & Shurtleff Inc·August 21, 2019

    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·December 4, 2019

    Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·October 20, 2021

    AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic use in ligament reconstruction.

    FDA Enforcement
    Class II ·Terminated·Cayenne Medical Inc.·July 18, 2018

    AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity.

    FDA Enforcement
    Class II ·Terminated·Summit Medical, Inc.·December 23, 2015

    Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 3CM MODEL Number:M0035452530 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

    FDA Enforcement
    Class II ·Terminated·Stryker Neurovascular·July 20, 2016

    Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves W/Wallet, Powderfree 1 Face Mask 1 Polylined Drape, 13" X 18" 1 ChloraPrep***, 3ml Applicator W/Insert 1 Pkg. Alcohol Swabsticks (3/Pkg.) 1 14" Extension Set W/Bionector*** 2 Dressing Sponges, 2" X 2" 1 Foam Strip, 8/5cm X 1cm 1 3M*** Tegaderm *** IV Dressing W/CHG, 2 1/2" X 4 1/2" *** Vygon MFG Dover, NH 03820***"

    FDA Enforcement
    Class II ·Terminated·Churchill Medical Systems, Inc.·September 25, 2013

    C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.

    FDA Enforcement
    Class II ·Terminated·PENTAX of America Inc·June 27, 2018

    Target Detachable Coils: TARGET HELICAL NANO 2MM X 2CM MODEL Number:M0035452020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

    FDA Enforcement
    Class II ·Terminated·Stryker Neurovascular·July 20, 2016

    CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessories of gel and fasteners. Individual Tyvek pouches are packaged as a box of 12. Rx only. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity and intra-operative diagnostic ultrasound.

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Inc·April 15, 2015