BEUDAMED
    29 results · 13ms · Sources: EU EUDAMED, US FDA

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    LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 4mm connector, 1 X REF: EL-200-4 and 10 X REF: EL-200-4, Manufactured by LiNA Medical ApS, Surgery Division.

    FDA Recall
    Terminated ·LINA Medical ApS Formervangen 5 Glostrup Denmark·Product code KNF·December 1, 2009

    LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Small loop, 8mm connector, 1 X REF: EL-160-8 and 10 X REF: EL-160-8, Manufactured by LiNA Medical ApS, Surgery Division.

    FDA Recall
    Terminated ·LINA Medical ApS Formervangen 5 Glostrup Denmark·Product code KNF·December 1, 2009

    LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 8mm connector, 1 X REF: EL-200-8 and 10 X REF: EL-200-8, Manufactured by LiNA Medical ApS, Surgery Division.

    FDA Recall
    Terminated ·LINA Medical ApS Formervangen 5 Glostrup Denmark·Product code KNF·December 1, 2009

    Pathfast D-Dimer, Reference number: PF1051-KUS

    FDA Enforcement
    Class II ·Terminated·Lsi Medience Corporation·November 30, 2016

    LAPAROSCOPY PACK CONTENTS: ( I ) BULB SYRINGE 60cc LIF ( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF ( I ) MAYO STAND COYER REINFORCED LIF ( I ) TABLE COVER REINFORCED 50" X 90" LIF (3) GOWN SURG. REINFORCED XL EXTRA LONG LEVEL I V (4) TOWEL ABSORBENT I 5" X 20" LIF ( I ) DRAPE VIDEO CAMERA I 3cm X 244cm LIF (3) LITE G LOVE LIF ( I ) DRAPE LAP ABDOM. WI POUCH 102" X 122" X 78" ( I ) BLADE SURG ICA L # II STAIN LESS STEEL ( I) SYRINGE I Occ W ITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE LIF ( I ) SUTURE BAG FLORAL (I) NEEDLE & BLADE COUNTER I OC MAG I C LEAR L/1' ( I ) CABLE LAP. IOFR 4MM MALE MONOP. LIF (2) DRESSING NON ADH TELfoA 4 X 3 ( I ) SPECIMEN CONTAINER 4oz WITH LID & LABEL (2) SH EET 'll.o 60" X 77" DRAPE R EI NFORCED LIF ( I ) TUBING INSUFFLAT SET WIO RING ADAPTOR LIF ( I ) CI-I LORAPREP 26ML APPLICATOR TEAL LIF ( I ) WRAPPER 24" X 24" (2) DENTURE CUP 8oz WILID ADHERED OUTSIDE OF THE PACK INTO A POUCH: ( I ) NEEDLE ULTRA VERES 1 20MM LIF ( I ) TROCAR ENDO.XCEL DILATING TIP IIM M (D IILT) ( I ) TROCA R ENDO.XCEL DILATING TIP LIF (K5LT) ( I ) CANNU LA 5MM XCEL SLEEVES LIF Product Usage: 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

    Pathfast D-Dimer, Reference number: PF1051-KUS

    FDA Recall
    Terminated ·Lsi Medience Corporation 13-4 Uchikanda·Product code GHH·August 16, 2016

    SPS Blue Line Tube Clamp Adapters, Product No. BL120M

    FDA Recall
    Terminated ·Southern Prosthetic Supply Co.·Product code ISH·October 3, 2006

    VSP Shock Module (as part of a prosthetic foot).

    FDA Recall
    Terminated ·Ossur North America Inc·Product code ISH·June 15, 2004

    VS-1000 Senator Prosthetic Foot, (Categories 5 and 6, sizes 22-30 cm, both Left and Right) Applied Composite Technology, Gunnison, UT.

    FDA Recall
    Terminated ·Applied Composite Technology·Product code ISH·June 20, 2007

    OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.

    FDA Recall
    Terminated ·Ossur Americas·Product code ISH·May 30, 2022

    JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;

    FDA Recall
    Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code FSH·February 23, 2017

    JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;

    FDA Recall
    Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code FSH·February 23, 2017

    Modular Knee Joint with Friction Brake

    FDA Recall
    Terminated ·Bock, Otto, Orthopedic Ind, Inc·Product code ISH·July 15, 2004

    Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated shock absorber, Model numbers RFXS0002, RFXS0003, RFLS0006 and RFL50007

    FDA Recall
    Terminated ·Ossur Grjothals 5 Reykjavik Ireland·Product code ISH·November 3, 2006

    iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.

    FDA Recall
    Terminated ·Otto Bock Healthcare GmbH Max-Nader-Str. # 15 Duderstadt Germany·Product code ISH·October 23, 2015

    Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other components. It is fully compatible with all standard 30mm prosthetic pylons. (3) Offset: 14,5mm (0.57inch).

    FDA Recall
    Terminated ·Ossur North America Inc·Product code ISH·October 24, 2013

    Thoracentesis/ Paracentesis Kit 10/CS; STERILE;

    FDA Recall
    Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code FSH·February 23, 2017

    ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE;

    FDA Recall
    Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code FSH·February 23, 2017

    Celsus prosthetic foot, Product Number 103658-00. The Celsus is intended for low impact level lower limb prosthesis users weighing up to 300 lbs.

    FDA Recall
    Terminated ·College Park Industries, Inc.·Product code ISH·April 5, 2012

    JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;

    FDA Recall
    Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code FSH·February 23, 2017