BEUDAMED
    19 results · 11ms · Sources: EU EUDAMED, US FDA

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    NOW RSV Test Item Number 430-430, Kit Number 430-00R

    FDA Recall
    Terminated ·Binax, Inc.·Product code GQG·February 18, 2004

    Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged in papercard carton. Catalog #256030.

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code GQG·December 15, 2003

    BinaxNOW RSV 10 Test Kit Part Number : 430-100, contains NP Swabs with '8995' labeled on the swab wrapper

    FDA Recall
    Terminated ·Binax, Inc. dba IMPD·Product code GQG·March 28, 2007

    Doyen-Collin Mouth Gag 120MM/ General Instruments

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code KBN·February 16, 2018

    Doyen-Collin Mouth Gag 120MM/ General Instruments

    FDA Enforcement
    Class III ·Terminated·Aesculap Implant Systems LLC·April 18, 2018

    Strauss Penis Clamp 130MM/General Instruments

    FDA Enforcement
    Class III ·Terminated·Aesculap Implant Systems LLC·April 18, 2018

    Strauss Penis Clamp 130MM/General Instruments

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code FHA·February 16, 2018

    -ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF ATB35 Lot 122300. -Ligaclip MCA Multiple Clip Applier, 20 Small Clips Small. REF MCS20 Lot 122300. - Ethicon Pistol Grip, Fixed Head Skin Stapler, Multi-Directional Release, (Grey) 35W. REF PXW35 Lot 122309 and Lot 123263. -Proximate Linear Cutter, w/o Staples 75mm. REF TLC75 Lot 122490 -Ethicon Proximate Plus MD, Skin Stapler Regular. REF PMR35 Lot 122753. -Proximate Plus, Rotating Head, Skin Stapler (White) Wide. REF PRW35 Lot 122406. - Ethicon PROXIMATE PLUS, Skin Stapler, Pistol Grip, Fixed Head, Multi-Directional Release, (Grey) Regular. REF PXR35 Lot 122675 and Lot 123263. -TX Reloadable Linear Stapler 3.5mm Leg, w/o Staples 60mm. Ref. TX60B Lot 122490 Manual surgical instrument for general use

    FDA Recall
    Terminated ·Surgical Instrument Service And Savings, Inc.·Product code GAG·May 3, 2013

    SurgASSIST System. Circular Stapler DLU 33 mm (product code CS33).

    FDA Recall
    Terminated ·Power Medical Interventions·Product code GAG·June 30, 2003

    EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.

    FDA Recall
    Terminated ·COVIDIEN LLC·Product code GAG·August 17, 2018

    Weck, DuraHook (6mm) and (12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales Units, 10 Sales Units per Shipper, Rx Only, Teleflex Medical, Research Triangle Park, NC 277809. For use as skin retraction devices during general surgery. DuraHooks are also cleared for use in procedures requiring retraction of dura mater.

    FDA Recall
    Terminated ·Teleflex Medical·Product code GDG·December 6, 2011

    PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117), and Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK 158). Skin stapler for use in a single patient, which is designed to apply rectangular stainless steel staples for routine wound closure.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code GAG·August 12, 2014

    Disposable Skin Stapler - 35 Wide; Surgical Skin Stapler; Rx, sterile, single use skin stapler, individually packaged in a thermo-formed tray with a Tyvek lid, 5 trays per box; Distributed by Cardinal Health, Dublin, OH 43017, Made in China; catalog number FS-35W. Designed to close incisions during a surgical procedure.

    FDA Recall
    Terminated ·Cardinal Health·Product code GAG·April 1, 2010

    SurgASSIST System. Circular Stapler DLU 29 mm (product code CS29)

    FDA Recall
    Terminated ·Power Medical Interventions·Product code GAG·June 30, 2003

    PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgical procedures.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code GAG·October 4, 2012

    Weck, DuraHook", Catalog #382800, 1/4" (6mm) Neuro Elastic Retractors, Sterile, Rx only.

    FDA Recall
    Terminated ·Telefelx Medical·Product code GDG·May 12, 2008

    Weck, DermaHook", Catalog #382805, 1/2" (12mm) Neuro Elastic Retractors, Sterile, Rx only, Weck Closure Systems, 2917 Weck Drive, Research Triangle Park, NC 27709

    FDA Recall
    Terminated ·Telefelx Medical·Product code GDG·May 12, 2008

    Weck, DermaHook (12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales Units, 10 Sales Units per Shipper, Rx Only, Teleflex Medical, Research Triangle Park, NC 277809. For use as skin retraction devices during general surgery. DuraHooks are also cleared for use in procedures requiring retraction of dura mater.

    FDA Recall
    Terminated ·Teleflex Medical·Product code GDG·December 6, 2011

    Presource Custom Sterile Packs containing the Cardiovascular Split Drape II; the custom sterile packs were packaged with the bulk, non-sterile drapes and then the complete custom pack was sterilized; packaged by Cardinal Health Medical Products and Services, McGaw Park, IL 60085; identified by the following catalog numbers: a) SVC13AMEMK - Sterile Open Heart Adult Pk; b) SCV31OHMPJ - Sterile Open Heart w Drapes Pk; c) SVC42OPVCG - Sterile Open Heart Adult Pack; d) SCV32CPMUO - Sterile CAB 146060 Pack; e) SCV34OHTMJ - Sterile Basin Pack; f) SCV31LVLUM - Sterile Liver Transplant Pack; g) SCV19CVHHF - Sterile Cardiovascular Pack; h) SCV11ADLLD - Sterile Open Heart/Adult; i) SCV92CBHRB - Sterile CABG Pack; j) SCV92CASIA - Sterile Cardiovascular Pack; k) SBA32GSMUL - Sterile General Surgery Pack; l) SCV30OHKWA - Strl **** Open Heart Pack; m) SBA31LVLUM - Sterile Liver Transplant Pack; n) SBA35LTBLQ - Sterile Lung Transplant Pack; o) SCV44CVDEB - Sterile CV Pack; p) SCV22OHMES - Open Heart Pack; q) SCV23AOSFH - Open Heart Part 3; r) SCV43OHHRF - Open Heart; s) SCV24CAGME - CABG Drape Pack; t) SAN12CCKGB - Cardiac Pack; u) SBA13BRBSE - Breast Reduction; v) SCV11CBNYP - CABG G 3; w) SCV11CESLB - C.V. Drape Pack; x) SCV11CGCPR - CABG; y) SCV11CGXXB - CABG Pack; z) SCV11CJICL - Cardiac Major; aa) SCV11CTMUK - C T Set Up; bb) SCV11DPMYG - **** S Drape Pack; cc) SCV11HEMMI - Open Heart A B; dd) SCV11MRCPE - Major Cardiac; ee) SCV11OCNYN - OH CABG; ff) SCV11OHLD2 - Open Heart A&B Pack; gg) SCV11OHNMC - Open Heart; hh) SCV11OPLKC - O P CABG; ii) SCV11VASLB - C V Valve Drape; jj) SCV11VLNYM - G 3 Valve; kk) SCV12OHYHY - Graft and Linen; ll) SCV13AABSV - Aortic Aneurysm; mm) SCV13AMEMJ - Open Heart Pack B; nn) SCV13BBEMC - Cardio-Thoracic Aux; oo) SCV13CB767 - CABG; pp) SCV13OHCAI - Open Heart Pk; qq) SCV13OOBIG - Open Heart Drape; rr) SCV14O1BGO - Open Heart Pack A; ss) SCV22OHPGA - Open Heart Pack; tt) SCV22OOMSE - Open Heart Preferred; uu) SCV24OH20A - Open Heart Drape Pack; vv) SCV43DREJI - Open Heart Drape Pack; ww) SCV69OH17E - Open Heart; xx) SCV59HVSGJ - Heart Valve Pack; yy) SCV59OHNVM - Open Heart Pack; zz) SCV53HTDMG - ***** Open Heart; aaa) SCV56CH11A - Open Heart Pack; bbb) SCV59MJTCW - Open Heart Pack; ccc) SCV52OH97F - Open Heart Pack; ddd) SCV41OHHIE - Open Heart Pack; eee) SCV52HTSJE - Open Heart Pack; fff) SCV59OHMHV - Basic Heart Pack; ggg) SCV11MJTJI - Open Heart

    FDA Recall
    Terminated ·Cardinal Health·Product code LRO·September 27, 2006