BEUDAMED
    1,098 results · 22ms · 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 FDA Recall × Status: Terminated × Clear all

    0.10% BreathScan Alcohol Detector manufactured for WNCK, Inc., The Woodlands, TX by Howard Industries, Inc., Columbus, OH (crystals) and James Alexander Corp., Blairstown, NJ (general device assembly). Product sold in bulk and individually packaged. Bulk product (500-1000 units) distributed in unlabeled clear plastic bags. Individually packaged product packaged and sealed in clear plastic bags with labeling and sold in boxes containing 100 units/box.

    FDA Recall
    Terminated ·WNCK, Inc·Product code DJZ·November 30, 2005

    StreamLab Analytical Workcell. General Purpose Laboratory Device.

    FDA Recall
    Terminated ·Dade Behring Inc. Rte 896, Glasgow Business Community·Product code JJE·November 12, 2004

    Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code FZX·February 16, 2016

    Retractors Model #'s: ADE3204 BOS820-175 LON3304 and LON3334-4G A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either resusable or disposable, intended to be used in various general surgical procedures.

    FDA Recall
    Terminated ·Sterilmed Inc·Product code GAD·August 8, 2008

    bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LIB·February 10, 2014

    DigitalDiagnost. General radiographic examinations and applications wherever a solid state X-ray imaging device can be used.

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code MQB·January 21, 2010

    Lap Instruments/Graspers/Forceps - COLD Model #'s: AUT173030 AUT174233 AUT174317 AUT176613 AUT176647 AUTECATCH10G and ETH5DSG A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either resusable or disposable, intended to be used in various general surgical procedures.

    FDA Recall
    Terminated ·Sterilmed Inc·Product code GDI·August 8, 2008

    Rasps Model #'s: KOMKM5100-37-113 KOMKM-82 STR1675-115 STR5100-37-113 and STR5100-37-115 A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either resusable or disposable, intended to be used in various general surgical procedures.

    FDA Recall
    Terminated ·Sterilmed Inc·Product code HTR·August 8, 2008

    Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code MLR·January 12, 2009

    Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bits, manual surgical instruments for general use. Item Nos. 0202024301 0202024325 0202024330 0202024342 0202024344 0202024346 0202024360 0202024362 47225806700

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code HRS·October 10, 2019

    STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·July 14, 2016

    CURVED-TIP STAPLER 30,IS4000; Model number 470530; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·July 14, 2016

    Multi-Clip Applier Model #'s: APPCA080 AUT134031 AUT134046 AUT134051 AUT134053 AUT176625 AUT176657 AUTPTACK30 ETHEL5ML ETHER320 ETHMCL20 ETHMCM20 ETHMCM30 ETHMCS20 ETHMSM20 and WEC543965 A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either resusable or disposable, intended to be used in various general surgical procedures.

    FDA Recall
    Terminated ·Sterilmed Inc·Product code HBT·August 8, 2008

    LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for general patient population.

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code OXQ·July 1, 2019

    STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code MLR·September 18, 2013

    ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code LXH·December 19, 2019

    STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code MLR·November 11, 2013

    STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code MLR·July 25, 2013

    Medical Device Exchange - GelPort Laparoscopic System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C8XX2N0NCE. EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.

    FDA Recall
    Terminated ·EXP Pharmaceutical Services Corp·Product code GCJ·February 11, 2015

    STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code MLR·November 11, 2013