BEUDAMED
    32 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362

    FDA Enforcement
    Class II ·Terminated·Vitreq Bv·February 5, 2020

    VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386

    FDA Enforcement
    Class II ·Terminated·Vitreq Bv·February 5, 2020

    PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·March 5, 2014

    Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma HP Instruments Balanced Surgical Technique, 0612-88-510 Sigma HP Instruments Fixed Reference Surgical Technique, 0612-87-510 PFC Sigma Knee Systems Primary Cruciate-Retaining & Cruciate-Substituting Procedure Surgical Technique,SP2-007 Product Usage: The SP2 IM Rod is used in both primary and revision Sigma knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is included in both the SP2 and HP instrument kits.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·March 27, 2013

    Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·January 18, 2017

    Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·February 15, 2017

    Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan.

    FDA Enforcement
    Class II ·Terminated·Nidek Inc·July 9, 2014

    Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Model Numbers: System Material # AXIOM Artis FC 05904433; AXIOM Artis FA 05904441; AXIOM Artis MP 05904466; AXIOM Artis BC 05904649; AXIOM Artis BA 05904656; AXIOM Artis dBC Mag. Nav. 05917054; AXIOM Artis TA 07007755; AXIOM Artis dTA 07008605; AXIOM Artis dFC 07412807; AXIOM Artis dTC 07413078; AXIOM Artis dBA 07555357; AXIOM Artis dMP 07555365; AXIOM Artis dFA 07555373; AXIOM Artis dFC Mag. Nav. 07727717; AXIOM Artis TC 07728350; AXIOM Artis dBC 07728392; Artis zee floor 10094135; Artis zee ceiling 10094137; Artis zee MP 10094139; Artis zee biplane 10094141; Artis zee floor MN 10094142; Artis zee biplane MN 10094143; Artis Q floor 10848280; Artis Q ceiling 10848281; Artis Q biplane 10848282; Artis Q.zen floor 10848353; Artis Q.zen ceiling 10848354; Artis Q.zen biplane 10848355.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 5, 2021

    AXIOM Artis dFC, Model Number 7727717

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    AXIOM Artis dFC, Model Number 7412807

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.

    FDA Enforcement
    Class II ·Terminated·Nidek Inc·September 4, 2013

    REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile

    FDA Enforcement
    Class II ·Terminated·Allergan PLC·February 10, 2021

    Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic) and minimally invasive arthroscopic procedures where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The electrosurgical device is intended for use with conventional monopolar electrosurgical electrodes. Item Code: FT3000F

    FDA Enforcement
    Class II ·Terminated·Covidien, PLC·March 27, 2019

    ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.

    FDA Enforcement
    Class II ·Terminated·Pfm Medical Inc·December 17, 2014

    ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.

    FDA Enforcement
    Class II ·Terminated·Pfm Medical Inc·December 17, 2014

    Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media.

    FDA Enforcement
    Class II ·Terminated·Pfm Medical Inc·December 17, 2014

    6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusions rate varies by catheter French size and is printed on the catheter.

    FDA Enforcement
    Class II ·Terminated·Pfm Medical Inc·December 17, 2014

    Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage

    FDA Enforcement
    Class II ·Terminated·Pfm Medical Inc·December 17, 2014

    ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen.

    FDA Enforcement
    Class II ·Terminated·Pfm Medical Inc·December 17, 2014

    Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage.

    FDA Enforcement
    Class II ·Terminated·Pfm Medical Inc·December 17, 2014