BEUDAMED
    290 results · 23ms · Sources: EU EUDAMED, US FDA

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    PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.

    FDA Recall
    Terminated ·Dako North America Inc.·Product code PLS·February 2, 2018

    ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOB·May 5, 2020

    QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms

    FDA Recall
    Terminated ·Microbiologics Inc·Product code JTR·February 18, 2020

    Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-12 MONOSOF* 2-0 BLK 100CM GCC90 CN-793 MONOSOF* 1 BLK 100CM GCC90 X36 CN-793-12 MONOSOF* 1 BLK 100CM GCC90X12 CN-830-L MONOSOF* 1 BLK 150CM LP GS25 N-2781K MONOSOF* 5-0 BLK 45CM SS24 DAX12 SN-1647 MONOSOF* 7-0 BLK 45CM P16 X36 SN-1647G MONOSOF* 7-0 BLK 45CM P16 X12 SN-247 MONOSOF* 3-0 BLK 90CM C23 X36 SN-3686 MONOSOF* 7-0 BLK 45CM P10 X12 SN-3695 MONOSOF* 5-0 BLK 45CM P10 X12 SN-3697 MONOSOF* 6-0 BLK 45CM P10 X12 SN-3965 MONOSOF* 5-0 BLK 45CM PC11 X12 SN-5660G MONOSOF* 6-0 BLK 45CM P24 X12 SN-5665G MONOSOF* 6-0 BLK 45CM P12 X12 SN-5690G MONOSOF* 5-0 CLR 45CM P13 X12 SN-5691 MONOSOF* 4-0 CLR 45CM P13 X36 SN-5694 MONOSOF* 4-0 BLK 45CM P11 X36 SN-5696 MONOSOF* 6-0 BLK 45CM P13 X36 SN-5697 MONOSOF* 6-0 BLK 45CM P10 X36 SN-5767G MONOSOF* 6-0 BLK 45CM P11 X12 SN-630 MONOSOF* 4-0 BLK 75CM C22 X36 SN-643 MONOSOF* 5-0 BLK 75CM C13 X36 SN-667G MONOSOF* 6-0 BLK 45CM C1 X12 SN-694 MONOSOF* 2-0 BLK 90CM C18 X36 SN-871 MONOSOF* 5-0 BLK 45CM C1 X36 SN-872 MONOSOF* 4-0 BLK 45CM C1 X36 SUT GNJ-283 MONOSOF 2/0 BLK ST DA 90CM SUT N-59 MONOSOF 2-0 BLK 6X45CM PCT

    FDA Recall
    Open, Classified ·Product code GAR·December 2, 2022

    FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #KNB21.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery·Product code GCJ·November 25, 2003

    Extron Electronics OEM, CAB, DVI-Male to DVI-Female Cable Assembly (14 inch.); Part #: 43-111-01 (Stryker Part #: 0100-224-131); Distributed by Stryker Communications, Flower Mound, TX 75028. (These cables are commonly used with the Switchpoint Infinity II)

    FDA Recall
    Terminated ·Stryker Communications·Product code GCJ·October 3, 2007

    Weck Vista" Universal Laparoscopic Port, Size 5/10/12mmx125mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.

    FDA Recall
    Terminated ·Teleflex Medical·Product code GCJ·March 11, 2014

    Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Recall
    Terminated ·Davol, Inc., Subs. C. R. Bard, Inc.·Product code GCJ·April 24, 2014

    Applied Medical's LAP CHOLE KIT 7 GK; Model Number: GK107 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·September 10, 2010

    Applied Medical's LAP CHOLE ; Model Number: K2155 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·September 10, 2010

    Applied Medical's LAP CHOLE KIT ; Model Number: K0492 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·September 10, 2010

    Endopath Probe Plus II, Curved Dissector Electrode, 5mm shaft, 34 cm length, hollow tip electrode, Code EPS04.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code GCJ·April 20, 2006

    Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code GCJ·June 25, 2008

    ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Dissector, 5mm x 33cm length, REF/Product Code 60-6040-003. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.

    FDA Recall
    Terminated ·Conmed Corporation·Product code GCJ·October 12, 2006

    24mm Rotating C-Mount Coupler, Model Number 1088-020-121S2. The device in indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope, endoscope or arthroscope is indicated for use.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code GCJ·March 31, 2008

    Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code GCJ·April 6, 2016

    DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.

    FDA Recall
    Open, Classified ·Aesculap Inc·Product code GCJ·January 9, 2024

    Medtronic Tourniquet Sets: a) DLP 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP 7 in (17.8 cm) Tourniquet Kit, Model Number 79009

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code GDJ·March 19, 2024

    5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2B5ST

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code GCJ·March 26, 2018

    5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code GCJ·March 26, 2018